Stress ulcer prophylaxis in adult intensive care unit patients – a protocol for a systematic review

Acta Anaesthesiologica Scandinavica

Volumn 62, Issue 6, 2018, Pages 744-755

  Barbateskovic, M ^a,b   Marker, S ^b   Jakobsen, J C ^a,c   Krag, M ^b   Granholm, A ^b   Anthon, C T ^b   Perner, A ^b   Wetterslev, J ^a,b   Moller M H ^b  

^a Centre for Clinical Intervention Research   (Denmark)

^b Rigshospitalet   (Denmark)

^c HOLBÆK HOSPITAL   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

HISTAMINE H2 RECEPTOR ANTAGONIST; SUCRALFATE; PROTON PUMP INHIBITOR;

ALL CAUSE MORTALITY; HUMAN; INTENSIVE CARE UNIT; MEAN ARTERIAL PRESSURE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; STOMACH MUCOSA; STRESS ULCER; SYSTEMATIC REVIEW (TOPIC); SYSTOLIC BLOOD PRESSURE; ADULT; CLINICAL PROTOCOL; COMPLICATION; MENTAL STRESS; META ANALYSIS; PEPTIC ULCER; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ADULT; CLINICAL PROTOCOLS; HUMANS; INTENSIVE CARE UNITS; PEPTIC ULCER; PROTON PUMP INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STRESS, PSYCHOLOGICAL;

EID: 85044413113     PISSN: 00015172     EISSN: 13996576     Source Type: Journal    
DOI: 10.1111/aas.13109     Document Type: Review

References (65)

1. Marik PE, Vasu T, Hirani A, Pachinburavan M. Stress ulcer prophylaxis in the new millennium: a systematic review and meta-analysis. Crit Care Med 2010; 38: 2222–8.
2. Sesler JM. Stress-related mucosal disease in the intensive care unit: an update on prophylaxis. AACN Adv Crit Care 2007; 18: 119–26; quiz 127-8.
3. Plummer MP, Blaser AR, Deane AM. Stress ulceration: prevalence, pathology and association with adverse outcomes. Crit Care 2014; 18: 213.
4. Eddleston JM, Pearson RC, Holland J, Tooth JA, Vohra A, Doran BH. Prospective endoscopic study of stress erosions and ulcers in critically ill adult patients treated with either sucralfate or placebo. Crit Care Med 1994; 22: 1949–54.
5. Martin LF. Stress ulcers are common after aortic surgery. endoscopic evaluation of prophylactic therapy. Am Surg 1994; 60: 169–74.
6. Peura DA, Johnson LF. Cimetidine for prevention and treatment of gastroduodenal mucosal lesions in patients in an intensive care unit. Ann Intern Med 1985; 103: 173–7.
7. Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Mcarthur C, Cook D, Nielsen N, Pelosi P, Keus F, Guttormsen AB, Moller AD, Moller MH, Co-Authors S-I. Prevalence and outcome of gastrointestinal bleeding and use of acid suppressants in acutely ill adult intensive care patients. Intensive Care Med 2015; 41: 833–45.
8. Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian critical care trials group. N Engl J Med 1994; 330: 377–81.
9. Reintam Blaser A, Poeze M, Malbrain ML, Bjorck M, Oudemans-Van Straaten HM, Starkopf J. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Med 2013; 39: 899–909.
10. Cook DJ, Griffith LE, Walter SD, Guyatt GH, Meade MO, Heyland DK, Kirby A, Tryba M. The attributable mortality and length of intensive care unit stay of clinically important gastrointestinal bleeding in critically ill patients. Crit Care 2001; 5: 368–75.
11. Maclaren R, Reynolds PM, Allen RR. Histamine-2 receptor antagonists vs proton pump inhibitors on gastrointestinal tract hemorrhage and infectious complications in the intensive care unit. JAMA Intern Med 2014; 174: 564–74.
12. Holst LB, Haase N, Wetterslev J, Wernerman J, Guttormsen AB, Karlsson S, Johansson PI, Aneman A, Vang ML, Winding R, Nebrich L, Nibro HL, Rasmussen BS, Lauridsen JR, Nielsen JS, Oldner A, Pettila V, Cronhjort MB, Andersen LH, Pedersen UG, Reiter N, Wiis J, White JO, Russell L, Thornberg KJ, Hjortrup PB, Muller RG, Moller MH, Steensen M, Tjader I, Kilsand K, Odeberg-Wernerman S, Sjobo B, Bundgaard H, Thyo MA, Lodahl D, Maerkedahl R, Albeck C, Illum D, Kruse M, Winkel P, Perner A; Group TT. Scandinavian critical care trials g lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med 2014;371:1381–91.
13. Marker S, Perner A, Wetterslev J, Barbateskovic M, Jakobsen JC, Krag M, Granholm A, Anthon CT, Moller MH. Stress ulcer prophylaxis versus placebo or no prophylaxis in adult hospitalised acutely ill patients-protocol for a systematic review with meta-analysis and trial sequential analysis. Syst Rev 2017; 6: 118.
14. Cook D, Heyland D, Griffith L, Cook R, Marshall J, Pagliarello J. Risk factors for clinically important upper gastrointestinal bleeding in patients requiring mechanical ventilation. canadian critical care trials group. Crit Care Med 1999; 27: 2812–7.
15. Barletta JF. Histamine-2-receptor antagonist administration and gastrointestinal bleeding when used for stress ulcer prophylaxis in patients with severe sepsis or septic shock. Ann Pharmacother 2014; 48: 1276–81.
16. Mcalhany JC Jr, Colmic L, Czaja AJ, Pruitt BA Jr. Antacid control of complications from acute gastroduodenal disease after burns. J Trauma 1976; 16: 645–8.
17. Cook D, Guyatt G, Marshall J, Leasa D, Fuller H, Hall R, Peters S, Rutledge F, Griffith L, Mclellan A, Wood G, Kirby A. A comparison of sucralfate and ranitidine for the prevention of upper gastrointestinal bleeding in patients requiring mechanical ventilation. Canadian critical care trials group. N Engl J Med 1998; 338: 791–7.
18. Frandah W, Colmer-Hamood J, Nugent K, Raj R. Patterns of use of prophylaxis for stress-related mucosal disease in patients admitted to the intensive care unit. J Intensive Care Med 2014; 29: 96–103.
19. Fohl AL, Regal RE. Proton pump inhibitor-associated pneumonia: not a breath of fresh air after all? World J Gastrointest Pharmacol Ther 2011; 2: 17–26.
20. Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, Mcintyre LA, Mclean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van Der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med 2017; 43: 304–77.
21. Krag M, Perner A, Wetterslev J, Moller MH. Stress ulcer prophylaxis in the intensive care unit: is it indicated? A topical systematic review. Acta Anaesthesiol Scand 2013; 57: 835–47.
22. Marker S, Krag M, Moller MH. What's new with stress ulcer prophylaxis in the icu? Intensive Care Med 2017; 43: 1132–4.
23. Alhazzani W, Alenezi F, Jaeschke RZ, Moayyedi P, Cook DJ. Proton pump inhibitors versus histamine 2 receptor antagonists for stress ulcer prophylaxis in critically ill patients: a systematic review and meta-analysis. Crit Care Med 2013; 41: 693–705.
24. Lin PC, Chang CH, Hsu PI, Tseng PL, Huang YB. The efficacy and safety of proton pump inhibitors vs histamine-2 receptor antagonists for stress ulcer bleeding prophylaxis among critical care patients: a meta-analysis. Crit Care Med 2010; 38: 1197–205.
25. Kantorova I, Svoboda P, Scheer P, Doubek J, Rehorkova D, Bosakova H, Ochmann J. Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial. Hepatogastroenterology 2004; 51: 757–61.
26. Pongprasobchai S, Kridkratoke S, Nopmaneejumruslers C. Proton pump inhibitors for the prevention of stress-related mucosal disease in critically-ill patients: a meta-analysis. J Med Assoc Thai 2009; 92: 632–7.
27. Barkun AN, Bardou M, Pham CQ, Martel M. Proton pump inhibitors vs. histamine 2 receptor antagonists for stress-related mucosal bleeding prophylaxis in critically ill patients: a meta-analysis. Am J Gastroenterol 2012; 107: 507–20; quiz 521.
28. Alshamsi F, Belley-Cote E, Cook D, Almenawer SA, Alqahtani Z, Perri D, Thabane L, Al-Omari A, Lewis K, Guyatt G, Alhazzani W. Efficacy and safety of proton pump inhibitors for stress ulcer prophylaxis in critically ill patients: a systematic review and meta-analysis of randomized trials. Crit Care 2016; 20: 120.
29. Liu BL, Li B, Zhang X, Fei Z, Hu SJ, Lin W, Gao DK, Zhang L. A randomized controlled study comparing omeprazole and cimetidine for the prophylaxis of stress-related upper gastrointestinal bleeding in patients with intracerebral hemorrhage. J Neurosurg 2013; 118: 115–20.
30. Selvanderan SP, Summers MJ, Finnis ME, Plummer MP, Ali Abdelhamid Y, Anderson MB, Chapman MJ, Rayner CK, Deane AM. Pantoprazole or placebo for stress ulcer prophylaxis (pop-up): randomized double-blind exploratory study. Crit Care Med 2016; 44: 1842–50.
31. Lin CC, Hsu YL, Chung CS, Lee TH. Stress ulcer prophylaxis in patients being weaned from the ventilator in a respiratory care center: a randomized control trial. J Formos Med Assoc 2016; 115: 19–24.
32. Higgins JPT, GSE Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (Updated March 2011). 2011.
33. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D. The prisma statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009; 339: b2700.
34. Keus F, Wetterslev J, Gluud C, Van Laarhoven CJ. Evidence at a glance: error matrix approach for overviewing available evidence. BMC Med Res Methodol 2010; 10: 90.
35. Jakobsen JC, Wetterslev J, Winkel P, Lange T, Gluud C. Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods. BMC Med Res Methodol 2014; 14: 120.
36. Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, Guyatt GH, Harbour RT, Haugh MC, Henry D, Hill S, Jaeschke R, Leng G, Liberati A, Magrini N, Mason J, Middleton P, Mrukowicz J, O'connell D, Oxman AD, Phillips B, Schunemann HJ, Edejer T, Varonen H, Vist GE, Williams JW Jr, Zaza S; Group GW. Grading quality of evidence strength of recommendations. BMJ 2004;328:1490.
37. Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C. User Manual for Trial Sequential Analysis (Tsa). Available at: Www.Ctu.Dk/Tsa/Files/Tsa_Manual.Pdf (accessed 9 January 2018)
38. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003; 327: 557–60.
39. Harbord RM, Egger M, Sterne JA. A modified test for small-study effects in meta-analyses of controlled trials with binary endpoints. Stat Med 2006; 25: 3443–57.
40. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, Graphical Test. BMJ 1997; 315: 629–34.
41. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994; 50: 1088–101.
42. Revman. Review Manager (Revman) (Computer Program) VCTNCC, The Cochrane Collaboration, 2014. Available at: Http://Community.Cochrane.Org/Tools/Review-Production-Tools/Revman-5/Revma, 2018 N–DaJ.
43. Tsa. Trial Sequential Analysis (Tsa) (Computer Program) CTU, 2011. Available at: Www.Ctu.Dk/Tsa/ (accessed 9 January 2018).
44. Gradepro. Gradepro (computer program). McMaster University 2014. Available at: www.gradepro.org (accessed 9 January 2018).
45. Deeks JJ, Higgins JPT, Statistical Algorithms in Review Manager 5. 2010: RevMan 5.3.
46. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22: 719–48.
47. Demets DL. Stat Med 1987; 6: 341–50.
48. Jakobsen JC, Wetterslev J, Lange T, Gluud C. Viewpoint:taking into account risks of random errors when analysing multiple outcomes in systematic reviews. Cochrane Database Syst Rev 2016;3:ED000111.
49. Brok J, Thorlund K, Gluud C, Wetterslev J. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses. J Clin Epidemiol 2008; 61: 763–9.
50. Brok J, Thorlund K, Wetterslev J, Gluud C. Apparently conclusive meta-analyses may be inconclusive–trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses. Int J Epidemiol 2009; 38: 287–98.
51. Higgins JP, Whitehead A, Simmonds M. Sequential methods for random-effects meta-analysis. Stat Med 2011; 30: 903–21.
52. Imberger G, Gluud C, Boylan J, Wetterslev J. Systematic reviews of anesthesiologic interventions reported as statistically significant: problems with power, precision, and type 1 error protection. Anesth Analg 2015; 121: 1611–22.
53. Mascha EJ. Alpha, beta, meta: guidelines for assessing power and type i error in meta-analyses. Anesth Analg 2015; 121: 1430–3.
54. Pogue JM, Yusuf S. Cumulating evidence from randomized trials: utilizing sequential monitoring boundaries for cumulative meta-analysis. Control Clin Trials 1997; 18: 580–93; discussion 661-6.
55. Terkawi AS, Mavridis D, Flood P, Wetterslev J, Terkawi RS, Bin Abdulhak AA, Nunemaker MS, Tiouririne M. Does ondansetron modify sympathectomy due to subarachnoid anesthesia?: meta-analysis, meta-regression, and trial sequential analysis. Anesthesiology 2016; 124: 846–69.
56. Thorlund K, Devereaux PJ, Wetterslev J, Guyatt G, Ioannidis JP, Thabane L, Gluud LL, Als-Nielsen B, Gluud C. Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses? Int J Epidemiol 2009; 38: 276–86.
57. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 2008; 61: 64–75.
58. Gluud C TK, Engstrøm J, Wetterslev J, Brok J, Imberger G. User Manual for Trial Sequential Analysis (Tsa), Copenhagen Trial Unit 2011, Available at: Www.Ctu.Dk/Tsa/Files/Tsa_Manual.Pdf (accessed 9 January 2018).
59. Kulinskaya E, Wood J. Trial sequential methods for meta-analysis. Res Synth Methods 2014; 5: 212–20.
60. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Med Res Methodol 2009; 9: 86.
61. Turner RM, Bird SM, Higgins JP. The impact of study size on meta-analyses: examination of underpowered studies in cochrane reviews. PLoS ONE 2013; 8: e59202.
62. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann HJ. Grade: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336: 924–6.
63. Krag M, Perner A, Wetterslev J, Wise MP, Hylander Moller M. Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis. Intensive Care Med 2014; 40: 11–22.
64. Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA; Group P-P. Preferred reporting items for systematic review and meta-analysis protocols (prisma-p) 2015: elaboration and explanation. BMJ 2015; 350: g7647.
65. International Conference on Harmonisation Expert Working Group (ICH-EWG). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Ich Harmonised Tripartite Guideline. Guideline for Good Clinical Practice in Cfr & Ich Guidelines. Vol. 1, Barnett International/PAREXEL, 1997.