TY - JOUR

T1 - Timing of onset of gastrointestinal bleeding in the ICU

T2 - Protocol for a preplanned observational study

AU - Granholm, A.

AU - Lange, T.

AU - Anthon, C. T.

AU - Marker, S.

AU - Krag, M.

AU - Meyhoff, T. S.

AU - Wise, M. P.

AU - Borthwick, M.

AU - Bendel, S.

AU - Keus, F.

AU - Guttormsen, A. B.

AU - Schefold, J. C.

AU - Wetterslev, J.

AU - Perner, A.

AU - Møller, M. H.

PY - 2018/9

Y1 - 2018/9

N2 - BackgroundCritically ill patients are at risk of gastrointestinal bleeding, but clinically important gastrointestinal bleeding is rare. The majority of intensive care unit (ICU) patients receive stress ulcer prophylaxis (SUP), despite uncertainty concerning the balance between benefit and harm. For approximately half of ICU patients with gastrointestinal bleeding, onset is early, ie within the first two days of the ICU stay. The aetiology of gastrointestinal bleeding and consequently the balance between benefit and harm of SUP may differ between patients with early vs late gastrointestinal bleeding.MethodsThis is a protocol and statistical analysis plan for a preplanned exploratory substudy of the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP‐ICU) randomized clinical trial, comparing intravenous pantoprazole (40 mg once daily) with placebo in 3350 acutely ill adult ICU patients. We will describe baseline characteristics and assess the time to onset of the first clinically important episode of GI bleeding accounting for survival status and allocation to SUP or placebo. In addition, we will describe differences in therapeutic and diagnostic procedures used in patients with clinically important gastrointestinal bleeding according to early vs late bleeding and 90‐day vital status.ConclusionsThe study outlined in this protocol will provide detailed information on patient characteristics and the timing of onset of gastrointestinal bleeding in the patients enrolled in the SUP‐ICU trial. This may provide additional knowledge and incentives for future studies on which patients benefit from SUP.

AB - BackgroundCritically ill patients are at risk of gastrointestinal bleeding, but clinically important gastrointestinal bleeding is rare. The majority of intensive care unit (ICU) patients receive stress ulcer prophylaxis (SUP), despite uncertainty concerning the balance between benefit and harm. For approximately half of ICU patients with gastrointestinal bleeding, onset is early, ie within the first two days of the ICU stay. The aetiology of gastrointestinal bleeding and consequently the balance between benefit and harm of SUP may differ between patients with early vs late gastrointestinal bleeding.MethodsThis is a protocol and statistical analysis plan for a preplanned exploratory substudy of the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP‐ICU) randomized clinical trial, comparing intravenous pantoprazole (40 mg once daily) with placebo in 3350 acutely ill adult ICU patients. We will describe baseline characteristics and assess the time to onset of the first clinically important episode of GI bleeding accounting for survival status and allocation to SUP or placebo. In addition, we will describe differences in therapeutic and diagnostic procedures used in patients with clinically important gastrointestinal bleeding according to early vs late bleeding and 90‐day vital status.ConclusionsThe study outlined in this protocol will provide detailed information on patient characteristics and the timing of onset of gastrointestinal bleeding in the patients enrolled in the SUP‐ICU trial. This may provide additional knowledge and incentives for future studies on which patients benefit from SUP.

KW - gastrointestinal bleeding

KW - intensive care

KW - intensive care unit

KW - risk factors

KW - stress ulcer prophylaxis

U2 - 10.1111/aas.13144

DO - 10.1111/aas.13144

M3 - Journal article

C2 - 29761482

VL - 62

SP - 1165

EP - 1170

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 8

ER -