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Timing of onset of gastrointestinal bleeding in the ICU: Protocol for a preplanned observational study.
Granholm, A; Lange, T; Anthon, C T; Marker, S; Krag, M; Meyhoff, T S; Wise, M P; Borthwick, M; Bendel, S; Keus, F; Guttormsen, A B; Schefold, J C; Wetterslev, J; Perner, A; Møller, M H.
Afiliação
  • Granholm A; Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
  • Lange T; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Anthon CT; Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
  • Marker S; Center for Statistical Science, Peking University, Beijing, China.
  • Krag M; Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
  • Meyhoff TS; Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
  • Wise MP; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Borthwick M; Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
  • Bendel S; Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Keus F; Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
  • Guttormsen AB; Department of Adult Critical Care, University Hospital of Wales, Cardiff, UK.
  • Schefold JC; Pharmacy Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
  • Wetterslev J; Department of Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.
  • Perner A; Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
  • Møller MH; Department of Anaesthesia and Intensive Care, Haukeland University Hospital and Clinical Institute 1 UiB, Bergen, Norway.
Article em En | MEDLINE | ID: mdl-29761482
BACKGROUND: Critically 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. METHODS: This 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. CONCLUSIONS: The 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Idioma: En Revista: Acta Anaesthesiol Scand Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Dinamarca

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Idioma: En Revista: Acta Anaesthesiol Scand Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Dinamarca