Søren Marker1,2, Mette Krag1,2, Anders Perner1,2, Jørn Wetterslev2,3, Theis Lange4,5, Matt P Wise6, Mark Borthwick7, Stepani Bendel8, Frederik Keus9, Anne Berit Guttormsen10,11, Joerg C Schefold12, Bodil S Rasmussen2,13, Thomas Elkmann14, Morten Bestle2,15,16, Bjørn Arenkiel17, Jon H Laake18, Maj K Kamper19, Maarit Lång8, Malgorzata B Pawlowicz-Dworzanska20, Sari Karlsson21, Janne Liisanantti22, Nilanjan Dey23, Heidi Knudsen24, Anders Granholm1, Morten Hylander Møller1,2. 1. Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 2. Centre for Research in Intensive Care (CRIC), Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 3. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 4. Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark. 5. Center for Statistical Science, Peking University, Beijing, China. 6. Department of Adult Critical Care, University Hospital of Wales, Cardiff, UK. 7. Pharmacy Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. 8. Department of Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland. 9. Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 10. Department of Anaesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway. 11. Department of Clinical Medicine, UiB, Bergen, Norway. 12. Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. 13. Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark. 14. Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark. 15. Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. 16. Department of Anaesthesia and Intensive Care, Nordsjaelland Hospital, University of Copenhagen, Hillerød, Denmark. 17. Department of Anaesthesia and Intensive Care, Holbaek Hospital, Holbaek, Denmark. 18. Division of Emergencies and Critical Care, Department of Anaesthesiology, Rikshospitalet Medical Centre, Oslo University Hospital, Oslo, Norway. 19. Department of Anaesthesia and Intensive Care, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. 20. Department of Anaesthesia and Intensive Care, Regionshospitalet Nordjylland-Hjørring, Hjørring, Denmark. 21. Department of Intensive Care, Tampere University Hospital, Tampere, Finland. 22. Department of Anaesthesia and Intensive Care, Oulu University Hospital, Oulu, Finland. 23. Department of Anaesthesia and Intensive Care, Regionshospitalet Holstebro-Hospitalsenheden Vest, Holstebro, Denmark. 24. Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
Abstract
BACKGROUND: The long-term effects of stress ulcer prophylaxis with pantoprazole are unknown in ICU patients. We report 1-year mortality outcome in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial. METHODS: In the SUP-ICU trial, acutely admitted adult ICU patients at risk of gastrointestinal bleeding were randomised to intravenous pantoprazole 40 mg vs placebo (saline) once daily during their ICU stay. We assessed mortality at 1 year and did sensitivity analyses according to the trial protocol and statistical analysis plan. RESULTS:A total of 3261 of the 3291 patients with available data (99.1%) were followed up at 1 year after randomisation; 1635 were allocated topantoprazole and 1626 to placebo. At 1 year after randomisation, 610 of 1635 patients (37.3%) had died in the pantoprazole group as compared with 601 of 1626 (37.0%) in the placebo group (relative risk, 1.01; 95% confidence interval 0.92-1.10). The results were consistent in the sensitivity analysis adjusted for baseline risk factors and in those of the per-protocol population. We did not observe heterogeneity in the effect of pantoprazole vs placebo on 1-year mortality in the predefined subgroups, that is, patients with and without shock, mechanical ventilation, liver disease, coagulopathy, high disease severity (SAPS II > 53) or in medical vs surgical ICU patients. CONCLUSION: We did not observe a difference in 1-year mortality among acutely admitted adult ICU patients with risk factors for gastrointestinal bleeding allocated to stress ulcer prophylaxis withpantoprazole or placebo during the ICU stay. (The SUP-ICU trial was funded by Innovation Fund Denmark and others; ClinicalTrials.gov number, NCT02467621).
RCT Entities:
BACKGROUND: The long-term effects of stress ulcer prophylaxis with pantoprazole are unknown in ICU patients. We report 1-year mortality outcome in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial. METHODS: In the SUP-ICU trial, acutely admitted adult ICU patients at risk of gastrointestinal bleeding were randomised to intravenous pantoprazole 40 mg vs placebo (saline) once daily during their ICU stay. We assessed mortality at 1 year and did sensitivity analyses according to the trial protocol and statistical analysis plan. RESULTS: A total of 3261 of the 3291 patients with available data (99.1%) were followed up at 1 year after randomisation; 1635 were allocated to pantoprazole and 1626 to placebo. At 1 year after randomisation, 610 of 1635 patients (37.3%) had died in the pantoprazole group as compared with 601 of 1626 (37.0%) in the placebo group (relative risk, 1.01; 95% confidence interval 0.92-1.10). The results were consistent in the sensitivity analysis adjusted for baseline risk factors and in those of the per-protocol population. We did not observe heterogeneity in the effect of pantoprazole vs placebo on 1-year mortality in the predefined subgroups, that is, patients with and without shock, mechanical ventilation, liver disease, coagulopathy, high disease severity (SAPS II > 53) or in medical vs surgical ICU patients. CONCLUSION: We did not observe a difference in 1-year mortality among acutely admitted adult ICU patients with risk factors for gastrointestinal bleeding allocated to stress ulcer prophylaxis with pantoprazole or placebo during the ICU stay. (The SUP-ICU trial was funded by Innovation Fund Denmark and others; ClinicalTrials.gov number, NCT02467621).
Authors: Anders Granholm; Søren Marker; Mette Krag; Fernando G Zampieri; Hans-Christian Thorsen-Meyer; Benjamin Skov Kaas-Hansen; Iwan C C van der Horst; Theis Lange; Jørn Wetterslev; Anders Perner; Morten Hylander Møller Journal: Intensive Care Med Date: 2020-01-14 Impact factor: 17.440
Authors: Sine Wichmann; Theis S Itenov; Rasmus E Berthelsen; Theis Lange; Anders Perner; Christian Gluud; Pia Lawson-Smith; Lars Nebrich; Jørgen Wiis; Anne C Brøchner; Thomas Hildebrandt; Meike T Behzadi; Kristian Strand; Finn H Andersen; Thomas Strøm; Mikko Järvisalo; Kjeld A J Damgaard; Marianne L Vang; Rebecka R Wahlin; Martin I Sigurdsson; Katrin M Thormar; Marlies Ostermann; Frederik Keus; Morten H Bestle Journal: Acta Anaesthesiol Scand Date: 2022-08-09 Impact factor: 2.274