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<1>
Accession Number
2011675380
Authors
Lehmann N. Paul A. Moebus S. Budde T. Dobos G.J. Michalsen A.
Institution
(Lehmann, Moebus) Institute of Medical Informatics, Biometry and
Epidemiology, University Hospital Essen, Germany
(Paul, Dobos) Department of Internal and Integrative Medicine, Kliniken
Essen-Mitte, Essen, Germany
(Budde) Department of Cardiology, Alfried Krupp Hospital, Essen, Germany
(Michalsen) Institute of Social Medicine, Epidemiology and Health
Economics, Charite-University Medical Centre, Berlin, Germany
(Michalsen) Department of Internal and Integrative Medicine, Immanuel
Hospital Berlin, Berlin, Germany
Title
Effects of lifestyle modification on coronary artery calcium progression
and prognostic factors in coronary patients-3-Year results of the
randomized SAFE-LIFE trial.
Source
Atherosclerosis. 219 (2) (pp 630-636), 2011. Date of Publication:
December 2011.
Publisher
Elsevier Ireland Ltd (P.O. Box 85, Limerick, Ireland)
Abstract
Objective: Given the multimodal medical and interventional treatment
options in coronary artery disease (CAD), the current value of intensified
lifestyle modification remains unclear. No randomized studies have so far
assessed the impact of lifestyle modification on coronary artery calcium
(CAC). We examined the long-term effects of a one-year comprehensive
lifestyle modification on risk factors and CAC by means of a randomized
clinical trial. Methods: 96 participants (age range 35-75 years, 22 women)
of the SAFE-LIFE randomized trial in patients with established CAD
completed 3-year follow-up. The active treatment was a one-year lifestyle
modification and stress reduction intervention (LG), while the control
group received written advice only (AG). CAC (derived from electron beam
tomography), blood lipids, heart rate, blood pressure, anginal symptoms
and quality-of-life were assessed on entry and at 3-year follow-up.
Results: Lifestyle modification had no impact on change of CAC after three
years (median progression factor [25th,. 75th percentile] 1.46 [1.16,.
2.19] in LG and 1.41 [1.20,. 1.79] in AG; p= 0.68), but led to reductions
of blood pressure, heart rate and to dose-reductions in anti-ischemic
medications as compared to AG. Multiple regression analysis indicated that
in the pooled study population increase of CAC was related to psychosocial
factors and heart rate. Conclusion: In the presence of modern treatments,
complementary prescription of comprehensive lifestyle modification has no
impact on CAC progression but sustainable benefit for blood pressure,
heart rate and the need of anti-ischemic medication is demonstrated. A
possible influence of stress reduction measures on CAC progression should
be further evaluated. 2011 Elsevier Ireland Ltd.

<2>
Accession Number
2011664651
Title
Cardiovascular disorders associated with obstructive sleep apnea.
Source
Obstructive Sleep Apnea in Adults: Relationship with Cardiovascular and
Metabolic Disorders. Advances in Cardiology. 46 (pp 197-265), 2011.
Date of Publication: 2011.
Publisher
S. Karger AG (Allschwilerstrasse 10, P.O. Box, Basel CH-4009, Switzerland)
Abstract
Epidemiological, longitudinal and therapeutic studies have produced
convincing evidence that obstructive sleep apnea (OSA) is associated with
an increased risk of cardiovascular morbidity and mortality. The strongest
evidence supports an independent causal link between OSA and arterial
hypertension. OSA may be independently associated with an increased risk
for ischemic heart disease, stroke, arrhythmias and mortality. It remains
to be determined whether OSA is an independent cause of congestive heart
failure and pulmonary hypertension. Confounders and methodological biases
are the main reasons for the lack of definitive conclusions in causality
studies. Longitudinal studies, adequately powered randomized controlled
studies and therapeutic studies involving well-defined participants are
all needed to definitively answer the questions surrounding the
relationship between OSA and clinical cardiovascular outcomes,
comorbidities and intermediate pathogenic mechanisms. OSA is a modifiable
risk factor: continuous positive airway pressure administration, the gold
standard treatment of OSA, may reduce the early signs of endothelial
dysfunction and atherosclerosis, and improve cardiovascular outcomes, such
as the mortality related to cardiovascular events, blood pressure,
nonfatal coronary events and cardiac function in heart failure patients.
However, cardiac patients may not display the typical signs and symptoms
of OSA, such as an excessive body mass index and sleepiness. This fact,
and the cardiovascular risk associated with OSA, underlines the need for
collaborative guidelines to define a diagnostic strategy specifically
oriented toward the evaluation of OSA in cardiovascular patients.
Copyright 2011 S. Karger AG, Basel.

<3>
Accession Number
2011664507
Authors
Poncelet A.J. van Steenberghe M. Moniotte S. Detaille T. Beauloye C.
Bertrand L. Nassogne M.-C. Rubay J.E.
Institution
(Poncelet, van Steenberghe, Rubay) Cardiac Surgery Department, Universite
catholique de Louvain, Cliniques universitaires Saint-Luc, Avenue
Hippocrate 10, B-1200 Brussels, Belgium
(Moniotte) Pediatric Cardiology Department, Universite catholique de
Louvain, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, B-1200
Brussels, Belgium
(Detaille) Intensive Care Department, Universite catholique de Louvain,
Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, B-1200 Brussels,
Belgium
(Beauloye, Bertrand) Division of Cardiology, Universite catholique de
Louvain, Avenue Hippocrate 55, B-1200 Brussels, Belgium
(Nassogne) Pediatric Neurology Department, Universite catholique de
Louvain, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, B-1200
Brussels, Belgium
Title
Cardiac and neurological assessment of normothermia/warm blood
cardioplegia vs hypothermia/cold crystalloid cardioplegia in pediatric
cardiac surgery: Insight from a prospective randomized trial.
Source
European Journal of Cardio-thoracic Surgery. 40 (6) (pp 1384-1390), 2011.
Date of Publication: December 2011.
Publisher
Elsevier (P.O. Box 211, Amsterdam 1000 AE, Netherlands)
Abstract
Objective: Although normothermia and warm blood cardioplegia are widely
used in adults, cold crystalloids and hypothermia remain routinely used in
pediatric cardiac surgery. The superiority of either technique in both
brain and myocardial protection remains controversial. We designed a
prospective randomized study to compare both approaches in terms of early
myocardial protection and late neurodevelopmental status. Methods: From
2004 to 2005, 47 patients were randomly assigned to either mild
hypothermia associated to cold crystalloid cardioplegia (CCC, 22 patients)
or normothermia with intermittent warm blood cardioplegia (IWBC, 25
patients). Intramyocyte adenosine triphosphate (ATP) was measured before,
during and after cardioplegic arrest and results between groups were
compared. In addition to their cardiac status, early and late neurologic
assessment was performed by psychometric evaluation tests. Results:
Intracellular ATP levels were not significantly different between the two
groups. However, intragroup comparison revealed different profiles
according to myocardial protection: in the normothermia/warm blood
cardioplegia group, ATP concentration increased during cardioplegic arrest
and returned to initial values afterward (11nmolmg^-1 vs
21nmolmg^-1 vs 10nmolmg^-1, p<0.001), such changes did
not occur in the cold protocol (17nmolmg^-1 vs
19nmolmg^-1 vs 14nmolmg^-1, p=NS). Early neurological
outcome was similar in both groups. At late follow-up (mean=4 years), no
significant difference was observed between the two groups. Conclusions:
This study demonstrates that normothermia/IWBC protocols are not
deleterious when compared with more conventional approaches. A more
physiologic ATP steady state, reflecting the absence of cellular ischemic
insult was observed in the IWBC group. Importantly, no significant
difference was found between IWBC and CCC groups in terms of early and
late neurodevelopmental status. 2011 European Association for
Cardio-Thoracic Surgery.

<4>
Accession Number
2011667115
Authors
Mahmoudi M. Delhaye C. Waksman R.
Institution
(Mahmoudi, Delhaye, Waksman) Division of Cardiology, Department of
Internal Medicine, Washington Hospital Center, Washington, DC 20010,
United States
Title
Safety and efficacy of drug-eluting stents and bare metal stents in acute
coronary syndrome.
Source
Cardiovascular Revascularization Medicine. 12 (6) (pp 385-390), 2011.
Date of Publication: November 2011.
Publisher
Elsevier Inc. (360 Park Avenue South, New York NY 10010, United States)
Abstract
Compared with medical therapy, percutaneous coronary intervention has been
shown to reduce the rates of death and recurrent ischemia in patients
presenting with acute coronary syndromes (ACS). In the current
interventional era, both drug-eluting stents (DES) and bare-metal stents
(BMS) have been widely used, despite the fact that the use of DES in the
context of ACS was initially an "off-label" indication and that ACS has
been associated with stent thrombosis (ST). In contrast to the wealth of
data available for the use of DES in patients with ST-elevation myocardial
infarction, data regarding the performance of DES in non-ST-elevation ACS
is restricted to a handful of registries with conflicting data. The aim of
this review was to summarize the safety and efficacy of DES in the entire
spectrum of ACS. 2011.

<5>
Accession Number
2011666593
Authors
DeRossi R. Frazilio F.O. Jardim P.H.A. Martins A.R.C. Schmidt R.
Negrini-Neto J.M.
Institution
(DeRossi) Departments of Veterinary Medicine, Surgery and Anesthesiology,
Faculty of Veterinary Medicine and Animal Science, Federal University of
Mato Grosso do Sul, Campo Grande, MS, Brazil
(Jardim, Schmidt, Negrini-Neto) Veterinary Medicine, Faculty of Veterinary
Medicine and Animal Science, Federal University of Mato Grosso do Sul,
Campo Grande, MS, Brazil
(Frazilio, Martins) Department of Anesthesiology, School of Medicine, Sao
Paulo University, Sao Paulo, Brazil
Title
Evaluation of thoracic epidural analgesia induced by lidocaine, ketamine,
or both administered via a lumbosacral approach in dogs.
Source
American Journal of Veterinary Research. 72 (12) (pp 1580-1585), 2011.
Date of Publication: December 2011.
Publisher
American Veterinary Medical Association (1931 N. Meacham Road, Suite 100,
Schaumburg IL 60173-4360, United States)
Abstract
Objective-To determine the analgesic and systemic effects of thoracic
epidural administration of ketamine, lidocaine, or both in conscious dogs.
Animals-6 adult mixed-breed dogs. Procedures-Each dog received 2%
lidocaine hydrochloride without epinephrine (3.8 mg/ kg), 5% ketamine
hydrochloride (3.0 mg/kg), or both in randomized order with >= 1 week
between treatments. Drugs were administered in a total volume of 0.25
mL/kg through a thoracic epidural catheter implanted via the lumbosacral
approach. Heart rate, blood pressure, respiratory rate, rectal
temperature, analgesia, sedation, and ataxia were determined before
treatment (baseline [time 0]) and at 5, 10, 15, 20, 30, 40, 50, 60, 90,
120, 150, and 180 minutes after administration. Results-The main areas of
analgesia for the 3 treatments were the thorax and forelimbs bilaterally.
Median duration of analgesia was shorter after administration of ketamine
(30 minutes) than after administration of lidocaine (40 minutes) and
lidocaine plus ketamine (90 minutes). All treatments caused moderate motor
blockade, and only the ketamine and lidocaine plus ketamine treatments
caused mild sedation. Significant decreases in systolic and mean arterial
blood pressure were observed only with the lidocaine plus ketamine
treatment. Conclusions and Clinical Relevance-Thoracic epidural
administration of lidocaine plus ketamine resulted in longer duration of
analgesia of the thorax and forelimbs bilaterally in conscious dogs,
compared with administration of ketamine or lidocaine alone. Additional
studies are needed to determine whether this technique adequately relieves
postoperative pain after thoracic surgical procedures and whether it
causes respiratory depression in dogs.

<6>
Accession Number
2011652360
Authors
Du J. Huang Y.-G. Yu X.-R. Zhao N.
Institution
(Du) Department of Anaesthesiology, Subei People's Hospital, Yangzhou
University, Yangzhou, Jiangsu 225001, China
(Huang, Yu) Department of Anaesthesiology, Peking Union Medical College
Hospital, Beijing 100730, China
(Zhao) Department of Anaesthesiology, First Hospital, Qinghua University,
Beijing 100016, China
Title
Effects of preoperative ketamine on the endocrine-metabolic and
inflammatory response to laparoscopic surgery.
Source
Chinese Medical Journal. 124 (22) (pp 3721-3725), 2011. Date of
Publication: 20111120.
Publisher
Chinese Medical Association (42 Dongsi Xidajie, Beijing 100710, China)
Abstract
Background Ketamine is hypothesized to reduce perioperative
endocrine-metabolic and inflammatory responses in cardiac surgery
patients. This randomized, placebo-controlled, double-blind study was
performed to determine whether perioperative endocrine-metabolic and
inflammatory responses are attenuated by preoperative administration of
ketamine to healthy females receiving elective laparoscopic surgery.
Methods Forty female patients with American Society of Anesthesiologist
classification I or II who elected to receive gynecological laparoscopic
surgery were randomly assigned to the ketamine-treated (group K; n = 20)
or control (group C; n = 20) group. At 2 minutes prior to induction
patients in group K received ketamine (0.25 mg/kg) whereas those in group
C received normal saline. All patients received standardized general
anesthesia. Serum glucose and cortisol values were measured before
ketamine administration (T0), 2 minutes after tracheal intubation (T1), 30
minutes after skin incision (T2), 2 minutes after tracheal extubation (T3)
and 1 hour postoperatively (T4). Serum interleukin-6 and tumor necrosis
factor-alpha values were determined at T0 and T4. Postoperative analgesic
efficacy, side effects of administered drugs, and time to discharge were
recorded. Results Compared with subjects in group C, those in group K had
lower serum glucose values at T1, T2, T3 and T4 and lower serum cortisol
values at T4 (P <0.05). Postoperative interleukin-6 and tumor necrosis
factor-alpha concentrations for group K were lower than those for group C
(P <0.05). Postoperative visual analog scale scores at rest, cumulative
fentanyl consumption, and time to discharge were lower in group K as
compared to group C (P <0.05). No significant differences in drug side
effects were observed postoperatively between the two groups. Conclusion
Endocrine-metabolic and inflammatory responses to laparoscopic surgery are
attenuated in part by pre-incisional administration of ketamine.

<7>
Accession Number
2011671288
Authors
Nijjer S.S. Watson G. Athanasiou T. Malik I.S.
Institution
(Nijjer, Watson, Malik) Cardiology Department, Cardiovascular Sciences and
the Renal Institute, Hammersmith Hospital Campus, Du Cane Road, London W12
0HS, United Kingdom
(Athanasiou) Department of Surgery and Cancer, St Mary's Hospital Campus,
Imperial College London, United Kingdom
Title
Safety of clopidogrel being continued until the time of coronary artery
bypass grafting in patients with acute coronary syndrome: A meta-analysis
of 34 studies.
Source
European Heart Journal. 32 (23) (pp 2970-2988), 2011. Date of
Publication: December 2011.
Publisher
Oxford University Press (Great Clarendon Street, Oxford OX2 6DP, United
Kingdom)
Abstract
Aims Guidelines suggest that patients should discontinue clopidogrel for 5
days prior to coronary artery bypass grafting (CABG) where possible. Those
with acute coronary syndrome (ACS) are at elevated risk of further
myocardial infarction (MI) and death without clopidogrel. This
meta-analysis Aims to determine the risk of CABG in ACS patients while
continuing clopidogrel. Method and results Thirty-four studies with 22 584
patients undergoing CABG were assessed. Patients with recent clopidogrel
exposure (CL) were compared with those without recent clopidogrel (NC).
Although mortality is increased in CL vs. NC [odds ratio (OR) 1.6, 95 CI
1.301.96, P < 0.00001], it is influenced by the ACS status and case
urgency in these mainly non-randomized studies. In ACS patients, there is
no significant difference in mortality (OR 1.44, 95 CI 0.972.1, P = 0.07)
or in postoperative MI (OR 0.57, 95 CI 0.311.07, P = 0.08) and stroke
rates (OR 1.23, 95 CI 0.662.29, P = 0.52). Combined major adverse
cardiovascular event (stroke, MI, and death) was not different in the two
groups (OR 1.10, 95 CI 0.871.41, P = 0.43). Reoperation rates are elevated
on clopidogrel but have reduced over time, and were specifically not
different in ACS patients (OR 1.5, 95 CI 0.882.54, P = 0.13). Conclusion
Previous studies focused on surrogate endpoints and compared higher risk
ACS patients with elective cases. However, many patients have safely
undergone CABG on clopidogrel and surgical expertise is growing.
Multinational trials are required to fully determine the balance of
ischaemia and bleeding. While results are awaited we suggest ACS patients
requiring urgent CABG proceed with surgery without delay for a
clopidogrel-free period. 2011 The Author.

<8>
Accession Number
2011658166
Authors
Restrepo R.D. Wettstein R. Wittnebel L. Tracy M.
Institution
(Restrepo, Wettstein, Wittnebel) Department of Respiratory Care, The
University of Texas Health Sciences Center at San Antonio, San Antonio,
TX, United States
(Tracy) Department of Respiratory Therapy, Rainbow Babies and Children's
Hospital, Cleveland, OH, United States
Title
Incentive Spirometry: 2011.
Source
Respiratory Care. 56 (10) (pp 1600-1604), 2011. Date of Publication:
October 2011.
Publisher
Daedalus Enterprises Inc. (9425 North MacArthur Blvd, Suite 100, Irving TX
75063, United States)
Abstract
We searched the MEDLINE, CINAHL, and Cochrane Library databases for
articles published between January 1995 and April 2011. The update of this
clinical practice guideline is the result of reviewing a total of 54
clinical trials and systematic reviews on incentive spirometry. The
following recommendations are made following the Grading of
Recommendations Assessment, Development, and Evaluation (GRADE) scoring
system. 1: Incentive spirometry alone is not recommended for routine use
in the preoperative and postoperative setting to prevent postoperative
pulmonary complications. 2: It is recommended that incentive spirometry be
used with deep breathing techniques, directed coughing, early
mobilization, and optimal analgesia to prevent postoperative pulmonary
complications. 3: It is suggested that deep breathing exercises provide
the same benefit as incentive spirometry in the preoperative and
postoperative setting to prevent postoperative pulmonary complications. 4:
Routine use of incentive spirometry to prevent atelectasis in patients
after upper-abdominal surgery is not recommended. 5: Routine use of
incentive spirometry to prevent atelectasis after coronary artery bypass
graft surgery is not recommended. 6: It is suggested that a
volume-oriented device be selected as an incentive spirometry device.
2011 Daedalus Enterprises.

<9>
Accession Number
70604268
Authors
Guay J.Y.
Institution
(Guay) Maisonneuve-Rosemont Hospital, University of Montreal, Montreal,
QC, Canada
Title
General anesthesia does not contribute to long term postoperative
cognitive dysfunction in adults: A meta-analysis.
Source
Anesthesia and Analgesia. Conference: 2011 Annual Meeting of the
International Anesthesia Research Society, IARS 2011 Vancouver, BC Canada.
Conference Start: 20110521 Conference End: 20110524. Conference
Publication: (var.pagings). 112 (5 SUPPL. 1) , 2011. Date of
Publication: May 2011.
Publisher
Lippincott Williams and Wilkins
Abstract
Introduction : This is a meta-analysis evaluating the effects of the
anesthetic technique (regional vs. general anesthesia) on postoperative
cognitive dysfunction of patients undergoing noncardiac surgery. Methods :
A search for randomized controlled trials (RCT) comparing regional
anesthesia to general anesthesia for surgery was done in the American
National Library of Medicine's PUBMED in August 2009, in MEDLINE 1950 to
July 2009, 31; EMBASE 1980 to 2009 Week 32; EBM Reviews-Cochrane Central
Register of Controlled Trials 3rd Quarter 2009; PsychINFO 1806 to August
Week 1, 2009; Current Contents/All Editions 1993 Week 27 to 2009 Week 33.
Results : Twenty-six RCTs including 2365 patients: 1169 for regional
anesthesia and 1196 for general anesthesia were retained. The standardized
difference¹ in means for the tests included in the 26 RCTs was
-0.08 (95% Confidence Interval: -0.17 to 0.01; P value 0.094; I-squared =
0.00%). The assessor was blinded to the anesthetic technique for 12 of the
RCTs only including 798 patients: 393 for regional anesthesia and 405 for
general anesthesia. The standardized difference in means for these 12
studies is 0.05 (-0.10 to 0.20; P = 0.51; I-squared = 0.00%). Discussion :
The present meta-analysis does not support the concerns that a single
exposure to general anesthesia in an adult would significantly contribute
to permanent postoperative cognitive dysfunction after non-cardiac
surgery. (Table presented) .

<10>
Accession Number
70603954
Authors
Gatling J. Horricks J.E. Lauer R. Jamison R. Kim U. Applegate R.L.
Institution
(Gatling, Horricks, Lauer, Jamison, Applegate) Department of
Anesthesiology, Loma Linda University, School of Medicine, Loma Linda, CA,
United States
(Kim) Loma Linda University, School of Medicine, Loma Linda, CA, United
States
Title
Impact of tranexamic acid or epsilon aminocaproic acid on blood loss in
cardiac surgery: A randomized controlled trial.
Source
Anesthesia and Analgesia. Conference: 2011 Annual Meeting of the
International Anesthesia Research Society, IARS 2011 Vancouver, BC Canada.
Conference Start: 20110521 Conference End: 20110524. Conference
Publication: (var.pagings). 112 (5 SUPPL. 1) , 2011. Date of
Publication: May 2011.
Publisher
Lippincott Williams and Wilkins
Abstract
Introduction : Antifibrinolytics are routinely used for surgery with
cardiopulmonary bypass (CPB). Epsilon aminocaproic acid (E) and tranexamic
acid (T) have been shown to reduce bleeding and blood transfusion in this
population. While both have shown benefit compared to placebo, few studies
have directly compared them. Methods : IRB approved, double blind,
randomized trial (NCT01248104) comparing impact of E or T on blood loss
following CPB, in consenting adults undergoing primary cardiac surgery.
Exclusions included multiple valve, ascending aorta reconstruction or
repeat sternotomy procedures. After induction of anesthesia: E received
100 mg/kg given over 15 minutes, followed by infusion of 10 mg/kg/hr; T
received 10 mg/kg over 15 min, followed by infusion of 1 mg/kg/hr. This
dosing reflects the relative potency of T to E. Infusions were continued
throughout surgery until 4 hours after separation from CPB. Drugs were
delivered in a blinded fashion in identical volumes and infusion rates
based on patient weight. All other care decisions such as invasive
monitoring, anesthetic technique, transfusion decisions, and postoperative
care were at the discretion of the attending physicians. Data collection
included demographics, type of surgery, duration of CPB/surgery and
outcomes including ventilator hours and length of stay. Impact on blood
loss was determined by POD2 change in Hb and RBC volume (estimated blood
volume*hematocrit change + PRBC*0.55; includes impact of blood loss and
transfusion following CPB). Statistical analysis with p<0.05 considered
significant was performed using JMP 8.0.2. Continuous data were compared
using the t-test. Ordinal and nominal data were compared using Chi-Square.
Results : Data from 51 patients (E=26; T=25) have been analyzed to date.
There were no intergroup differences in age, gender, BMI, baseline lab
values or surgery duration. Perioperative risk assessed by P-POSSUM was
numerically higher in E. Outcome measures were numerically worse in T
(Table 1) but did not reach statistical significance. Discussion : These
results suggest E and T may have different impacts on outcome after CPB.
While only 27% of subjects were transfused, lower than reported in a
recent comparison, T had a larger decrease in Hb with a larger decrease in
PRBC volume by POD2 despite more frequent and larger average volume PRBC
transfusion. Assessment of blood loss following CPB may be improved by
calculating change in Hb or RBC volume, since these reflect the result of
both blood loss and transfusion and may be less affected by differences in
blood volume.

<11>
Accession Number
70601611
Authors
Hartog C.S. Vlasakov V. Thomas-Rueddel D.O. Rueddel H. Hutagalung R.
Reinhart K.
Institution
(Hartog, Vlasakov, Thomas-Rueddel, Rueddel, Hutagalung, Reinhart)
Department of Anesthesiology and Intensive Care Medicine, Jena University
Hospital, Jena, Germany
(Hartog, Thomas-Rueddel, Rueddel, Reinhart) Center for Sepsis Control and
Care, Jena University Hospital, Jena, Germany
Title
Efficacy and safety of gelatin for fluid therapy in hypovolemia: A
systematic review and meta-analysis.
Source
Critical Care. Conference: Sepsis 2011 Beijing China. Conference Start:
20111026 Conference End: 20111028. Conference Publication: (var.pagings).
15 (pp S24), 2011. Date of Publication: 27 Oct 2011.
Publisher
BioMed Central Ltd.
Abstract
Introduction Gelatin is frequently used as volume expander. There are
growing concerns about safety. Objective To systematically assess clinical
evidence concerning mortality, coagulation and renal function. Methods
Systematic review of randomised controlled trials (RCT) on gelatin in
hypovolemia in comparison to any other fluid with a comprehensive search
strategy (Ovid Medline (1948 to May 2011), EMBASE (1947 to May 2011),
Cochrane Library). Data were independently extracted and risk of bias
assessed using the 2010 Cochrane tool. Primary outcome was overall
mortality. Secondary outcomes were the number of patients exposed to
allogeneic transfusion, frequency of renal replacement therapy (RRT) or
acute renal failure (ARF). Albumin and crystalloid solutions were defi ned
as suitable, and other synthetic colloids as unsuitable control fluids
since they carry similar risk of side effects. Relative risks (RR) and
weighted mean differences with 95% CIs were calculated. Data were pooled
using a random-effects model (RevMan 5.1, Cochrane Collaboration). Results
The search yielded 1,288 citations, 210 reports were read in full. The fi
nal sample contained 72 RCT in English, German, French and Italian,
published between 1975 and 2010, with 5,915 patients overall, 2,523 of
which received gelatin. The median sample size in the gelatin groups was
20 patients (range 10 to 249). In 53 RCT (74%), the study period was
<=24.0 hours. Total gelatin dose was 20 ml/kg (median, range 6 to 62).
Only 38 RCT (53%) used suitable control fluids. Fortynine RCT (68%)
investigated elective surgical patients, mostly from cardiac surgery (32
RCT, 44%). Nine RCT (13%) investigated critically ill patients, six RCT
(8%) were in emergency patients and seven RCT (10%) were in children. The
RR for mortality was 1.02 (CI 0.87 to 1.19, data from 23 RCT with 2,694
patients which reported mortality). Numbers of patients exposed to
allogeneic transfusions were provided in 11 RCT, n = 1,148 patients and
the RR was 1.16 (0.94 to 1.44). When only studies with suitable control
fluids were included, the RR for mortality was 1.13 (0.88 to 1.46, 10 RCT,
1,392 patients) and risk for transfusion exposure was 1.35 (0.88 to 2.08,
seven RCT, n = 672), tending towards control. Only six RCT (n = 662
patients) reported the occurrence of RRT or ARF, fi ve of them in
comparison with HES solutions. Three RCT reported anaphylactoid events.
Conclusion Most published studies on gelatin are small and shorttime, use
unsuitable control fluids and report too few events to reliably assess the
safety of gelatin.