Format

Send to

Choose Destination
N Engl J Med. 2018 Dec 6;379(23):2199-2208. doi: 10.1056/NEJMoa1714919. Epub 2018 Oct 24.

Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU.

Collaborators (198)

Anders A, Walsh T, Forman JL, Marker S, Krag M, Granholm A, Anthon CT, Meyhoff TS, Møller MH, Perner A, Jarnvig IL, White JO, Brand B, Madsen MB, Thornberg KJ, Quist L, Wiis J, Møller A, Hjortrup PB, Kjær MN, Uhre KR, Degn J, Nielsen RD, Sølling C, Berntsen M, Topp NH, Møller K, Rasmussen BS, Aagaard SR, Andreasen JB, Sørensen CA, Haure P, Hauge J, Levin M, Jensen K, Søndergaard LS, Bundgaard H, Vang ML, Pælestik KB, Andersen KLD, Jensen DF, Grøfte T, Poulsen C, Andersen JK, Irion L, Winding R, Mærkedahl R, L Rasmussen M, Ravn T, Læbel RL, Tarpgaard M, Nielsen RP, Mahler LF, Dey N, Lodahl D, Andersen RVM, Midtgaard LB, Liboriussen L, Sølling CG, Knudsen KK, Pedersen SK, Ali A, Nielsen A, Møller-Nielsen N, Brødløs H, Koefoed M, Jensen KV, Breum O, Christensen S, Bülow HH, Elkjær J, Arenkiel B, Medici RB, Mollerup TK, Gasbjerg KS, Bestle MH, Sigurdsson ST, Hein L, Skram TU, Ibsen M, Østergaard M, Valbjørn L, Lauritzen S, Berezowicz P, Buus L, Iversen SA, Jensen JV, Kjer CKW, Poulsen LM, Estrup S, Pawlowicz MB, Kruse M, Guldager H, Kamper MK, Palmqvist DF, Stoktoft SA, Meyhoff CS, Elkmann T, Fjølner J, Lundholm L, Pedersen SHB, Walli A, Christensen H, Knudsen H, Schefold JC, Takala J, Jakob SM, Berger D, Zante B, Pfortmueller CA, Waskowski J, Hess B, Zürcher P, Jong M, Zacharias D, Lensch M, Siegemund M, Hollinger A, Scheuzger J, Tuscherer D, Vuilliomenet T, Schweingruber T, Siegemund P, Gebhard CE, Gantner L, Ledergerber K, Zimmermann S, Flükiger J, Yeginsoy D, Bizzozzero C, Gübelin L, Keus F, van der Horst ICC, Dieperink W, Onrust M, Zandijk E, Brormans L, Laake JH, Kåsine T, Akselsen GR, Baadstoeloekken PM, Martin Y, Flückiger M, Hoff M, Guttormsen AB, Sjøbø B, Strand K, Bendel S, Karttunen J, Rissanen N, Parviainen I, Uusaro A, Lång M, Rissanen S, Vaskelainen E, Halonen E, Rahikainen S, Bäcklund M, Valkonen M, Suhonen T, Sutinen S, Pettilä L, Liisanantti JH, Karhu J, Sälkiö S, Erikson K, Karlsson S, Kuitunen A, Jalkanen V, Långsjö J, Hoppu S, Varila S, Kukkurainen A, Grönlund J, Järvisalo SM, Takala R, Heiro J, Valtonen M, Inkinen O, Arola O, Siirala W, Kaskinoro K, Kentala S, Loikas E, Haltia P, Leivo K, Bredenberg E, Kunnola E, Wise MP, Morgan MPG, Cole J, Cocks E, Curtin J, Brooks J, Hill H, Davies R, Whitton C, Palmer N.

Author information

1
From the Department of Intensive Care (M.K., S.M., A.P., I.-L.J., J.O.W., B.B., M.B.M., L.Q., K.J.T., A.M., J. Wiis, A.G., C.T.A., T.S.M, P.B.H., M.H.M.), Copenhagen Trial Unit, Center for Clinical Intervention Research (J. Wetterslev, J.E.), and the Department of Neurointensive Care (R.D.N, C.S.), Rigshospitalet, Bispebjerg and Frederiksberg Hospital (D.F.P.), and the Section of Biostatistics (T.L.), University of Copenhagen, Copenhagen, Center for Research in Intensive Care (M.K., S.M., A.P., J. Wetterslev, B.S.R., T.L., B.A.-L., M.H.M.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A., J.B.A., C.A.S., P.H., J. Hauge), Randers Hospital, Randers (H.B., M.L.V., K.B.P., K.L.D.A.), Aarhus University Hospital, Nørrebrogade (T.E., J.F.), and Aarhus University Hospital, Skejby (O.B.) - both in Aarhus, Zealand University Hospital, Køge (J.V.J., C.K.W.K.), Viborg Hospital, Viborg (L.L., C.G.S.), Nordsjællands Hospital, University of Copenhagen, Hillerød (M.H.B.), Holbæk Hospital, Holbæk (J.M.E.), Zealand University Hospital, Roskilde (A.W.), Herning Hospital, Herning (R.W.), and Slagelse Hospital, Slagelse (S.I.) - all in Denmark; the Center for Statistical Science, Peking University, Beijing (T.L.); University Hospital of Wales, Cardiff (M.P.W., M.P.G.M.), and Oxford University Hospitals NHS Foundation Trust, Oxford (M. Borthwick) - both in the United Kingdom; Inselspital, Bern University Hospital, University of Bern, Bern (J.C.S., J.T., S.M.J.), and Basel University Hospital, Basel (M.S., A.H., J.S., D.T., T.V.) - both in Switzerland; University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (F.K., I.C.C.H., W.D.); Haukeland University Hospital, University of Bergen, Bergen (A.B.G., B.S.), and Oslo University Hospital (J.H.L.) and Akershus University Hospital (P.M.B.), Oslo - all in Norway; and Kuopio University Hospital, Kuopio (S.B., J.K.), Helsinki University Hospital, Helsinki (M. Bäcklund), and Turku University Hospital, Turku (J.G.) - all in Finland.

Abstract

BACKGROUND:

Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.

METHODS:

In this European, multicenter, parallel-group, blinded trial, we randomly assigned adults who had been admitted to the ICU for an acute condition (i.e., an unplanned admission) and who were at risk for gastrointestinal bleeding to receive 40 mg of intravenous pantoprazole (a proton-pump inhibitor) or placebo daily during the ICU stay. The primary outcome was death by 90 days after randomization.

RESULTS:

A total of 3298 patients were enrolled; 1645 were randomly assigned to the pantoprazole group and 1653 to the placebo group. Data on the primary outcome were available for 3282 patients (99.5%). At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died (relative risk, 1.02; 95% confidence interval [CI], 0.91 to 1.13; P=0.76). During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo (relative risk, 0.96; 95% CI, 0.83 to 1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, as compared with 4.2% in the placebo group. The number of patients with infections or serious adverse reactions and the percentage of days alive without life support within 90 days were similar in the two groups.

CONCLUSIONS:

Among adult patients in the ICU who were at risk for gastrointestinal bleeding, mortality at 90 days and the number of clinically important events were similar in those assigned to pantoprazole and those assigned to placebo. (Funded by Innovation Fund Denmark and others; SUP-ICU ClinicalTrials.gov number, NCT02467621 .).

PMID:
30354950
DOI:
10.1056/NEJMoa1714919
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center