Time to onset of gastrointestinal bleeding in the SUP-ICU trial: A pre-planned substudy.

Tytuł:: Time to onset of gastrointestinal bleeding in the SUP-ICU trial: A pre-planned substudy.
Autorzy:: Granholm A; Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Lange T; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.; Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.; Center for Statistical Science, Peking University, Beijing, China.
Anthon CT; Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Marker S; Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Krag M; Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Meyhoff TS; Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Wise MP; Department of Adult Critical Care, University Hospital of Wales, Cardiff, UK.
Borthwick M; Pharmacy Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Bendel S; Department of Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.
Keus F; Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Guttormsen AB; Department of Anaesthesia and Intensive Care, Department of Clinical Medicine, Haukeland University Hospital, UiB, Bergen, Norway.
Schefold JC; Department of Intensive Care Medicine, Inselspital, University of Bern, Bern, Switzerland.
Wetterslev J; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Perner A; Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Møller MH; Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Źródło:: Acta anaesthesiologica Scandinavica [Acta Anaesthesiol Scand] 2019 Nov; Vol. 63 (10), pp. 1346-1356. Date of Electronic Publication: 2019 Sep 11.
Typ publikacji:: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Publication: Oxford, UK : Wiley-Blackwell
Original Publication: Aarhus, Denmark : Universitetsforlaget, 1957-
MeSH Terms:: Gastrointestinal Hemorrhage/*etiology
Peptic Ulcer/*prevention & control
Stress, Psychological/*complications
Aged ; Female ; Humans ; Intensive Care Units ; Male ; Middle Aged ; Proportional Hazards Models ; Simplified Acute Physiology Score ; Time Factors
References:: Cook DJ, Griffith LE, Walter SD, et al. The attributable mortality and length of intensive care unit stay of clinically important gastrointestinal bleeding in critically ill patients. Crit Care. 2001;5:368-375.
Krag M, Perner A, Wetterslev J, et al. Prevalence and outcome of gastrointestinal bleeding and use of acid suppressants in acutely ill adult intensive care patients. Intensive Care Med. 2015;41:833-845.
Rhodes A, Evans LE, Alhazzani W, et al. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med. 2017;43:304-377.
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. Crit Care Med. 1999;27:2812-2817.
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;174:564-574.
Charlot M, Ahlehoff O, Norgaard ML, et al. Proton-pump inhibitors are associated with increased cardiovascular risk independent of clopidogrel use: a nationwide cohort study. Ann Intern Med. 2010;153:378-386.
Barbateskovic M, Marker S, Granholm A, et al. Stress ulcer prophylaxis with proton pump inhibitors or histamin-2 receptor antagonists in adult intensive care patients: a systematic review with meta-analysis and trial sequential analysis. Intensive Care Med. 2019;45:143-158.
Mircea N, Jianu E, Constantinescu C, et al. Stress ulcers in intensive care (etiology, symptomatology and therapy). Resuscitation. 1984;12:59-76.
Krag M, Marker S, Perner A, et al. Pantoprazole in patients at risk for gastrointestinal bleeding in the ICU. N Engl J Med. 2018;379:2199-2208.
Granholm A, Lange T, Anthon CT, et al. Timing of onset of gastrointestinal bleeding in the ICU: Protocol for a preplanned observational study. Acta Anaesthesiol Scand. 2018;62:1165-1170.
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: Guidelines for reporting observational studies. J Clin Epidemiol. 2008;61:344-349.
Krag M, Perner A, Wetterslev J, et al. Stress ulcer prophylaxis in the intensive care unit trial: detailed statistical analysis plan. Acta Anaesthesiol Scand. 2017;61:859-868.
Krag M, Perner A, Wetterslev J, et al. Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial. Trials. 2016;17:205.
Beyersmann J, Allignol A, Schumacher M. Competing risks and multi-state models with R. New York: Springer; 2012.
Le Gall J-R, Lemeshow S, Saulnier F. A new simplified acute physiology score (SAPS II) based on a European/North American multicenter study. JAMA. 1993;270:2957-2963. [Erratum, JAMA. 1994;271:1321].
Therneau T, Crowson C, Atkinson E. Using Time Dependent Covariates and Time Dependent Coefficients in the Cox Model. Available at: https://cran.r-project.org/web/packages/survival/vignettes/timedep.pdf [Last accessed 13 May 2019].
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17:162.
Marshall A, Altman DG, Holder RL, Royston P. Combining estimates of interest in prognostic modelling studies after multiple imputation: current practice and guidelines. BMC Med Res Methodol. 2009;9:57.
Vesin A, Azoulay E, Ruckly S, et al. Reporting and handling missing values in clinical studies in intensive care units. Intensive Care Med. 2013;39:1396-1404.
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;27:2812-2817.
Dal-Re R, Ioannidis JP, Bracken MB, et al. Making prospective registration of observational research a reality. Sci Transl Med. 2014;6:224cm1.
Thomas L, Peterson ED. The value of statistical analysis plans in observational research. JAMA. 2012;308:773-774.
Loder E, Groves T, MacAuley D. Registration of observational studies. BMJ. 2010;340:c950.
The PLOS Medicine. Editors. Observational studies: getting clear about transparency. PLoS Medicine. 2014;11:e1001711.
Colantuoni E, Scharfstein DO, Wang C, et al. Statistical methods to compare functional outcomes in randomized controlled trials with high mortality. BMJ. 2018;360:j5748.
Grant Information:: International Scandinavian Society of Anaesthesiology and Intensive Care Medicine; International Regions of Denmark; International Ehrenreich's Foundation; International European Society of Intensive Care Medicine; 4108-00011A International Innovation Fund Denmark; International Rigshospitalet; International Aase and Ejnar Danielsens Foundation; International Danish Society of Anaesthesiology and Intensive Care Medicine; International Capital Region of Denmark; International Danish Medical Association
Contributed Indexing:: Keywords: gastrointestinal bleeding; onset time; stress ulcer prophylaxis
Molecular Sequence:: ClinicalTrials.gov NCT02467621
Entry Date(s):: Date Created: 20190824 Date Completed: 20201109 Latest Revision: 20201109
Update Code:: 20240105
DOI:: 10.1111/aas.13459
PMID:: 31441031
: Czasopismo naukowe

Pełny tekst

Background: The aetiology and risk factors for clinically important gastrointestinal bleeding (CIB) in adult ICU patients may differ according to the onset of CIB, which could affect the balance between benefits and harms of stress ulcer prophylaxis (SUP).
Methods: We assessed the time to CIB in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial. We assessed if associations between baseline characteristics including allocation to SUP and CIB changed during time in the ICU, specifically in the later (after day 2) compared to the earlier (first 2 days) period, using Cox models adjusted for SAPS II and allocation to SUP. Additionally, we described baseline characteristics and CIB episodes stratified by earlier/later/no CIB and 90-day mortality status.
Results: Clinically important gastrointestinal bleeding occurred in 110/3291 (3.3%) patients after a median of 6 (interquartile range 2-13) days; 25.5% of the episodes occurred early. Higher SAPS II was consistently associated with increased risk of CIB (hazard ratio (HR) 1.03, 95% confidence interval (CI) 1.01-1.05 in the earlier period vs HR 1.02, 95% CI 1.01-1.03 in the later period; P = .37); university hospital admission was associated with decreased risk of earlier CIB (HR 0.30, 95% CI 0.14-0.63); this significantly increased in the later period (to HR 0.85, 95% CI 0.53-1.37; P = .02). Patients with later compared to earlier CIB received more transfusions and had more diagnostic/therapeutic procedures for CIB.
Conclusions: Clinically important gastrointestinal bleeding mostly occurred more than 2 days after randomization. University hospital admission was associated with significantly decreased risk of CIB in the earlier period only.
(© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Zaloguj się, aby uzyskać dostęp do pełnego tekstu.

Informacja