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Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis: Results of a Randomized Trial

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Schefold, Joerg C ; Krag, Mette ; Marker, Søren ; Perner, Anders ; Wetterslev, Jørn ; Wise, Matt P ; Borthwick, Mark ; Bendel, Stepani ; Keus, Frederik ; Guttormsen, Anne Berit ; Lange, Theis ; the SUP-ICU investigators ; Møller, Morten Hylander. / Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis : Results of a Randomized Trial. I: American Journal of Nephrology. 2019 ; Bind 50, Nr. 4. s. 312-319.

Bibtex

@article{22a4a28ded96412aa5ebc085297d3461,
title = "Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis: Results of a Randomized Trial",
abstract = "BACKGROUND: Intensive care unit (ICU) patients with acute kidney injury requiring renal replacement therapy (RRT) are considered at high risk of gastrointestinal (GI) bleeding and stress ulcer prophylaxis (SUP) is often prescribed. We aimed to assess the incidence of GI bleeding and effects of SUP in these patients.METHODS: We assessed GI bleeding in ICU patients receiving RRT at baseline (and at any time in the ICU) and effects of prophylactic pantoprazole versus placebo in the international SUP in the ICU (SUP-ICU) trial. All analyses were conducted according to a published protocol and statistical analysis plan.RESULTS: Data of 3,291 acutely admitted adult ICU patients with one or more risk factors for GI bleeding randomized to pantoprazole or placebo intravenously once daily during ICU stay (until ICU discharge, death, or a maximum of 90 days) were analyzed. Some 20 out of 258 (7.8{\%}, 95{\%} CI 4.5-11.1{\%}) and 52 out of 568 (9.2{\%}, 95{\%} CI 6.8-11.6{\%}) of the patients receiving RRT at baseline and at any time in ICU, respectively, developed clinically important GI bleeding in the ICU. We did not observe statistically significant differences in the intervention effect (pantoprazole vs. placebo) in the proportion of patients with clinically important GI bleeding, clinically important events, infectious adverse events, use of interventions to stop GI bleeding, or 90-day mortality in patients with versus without RRT at baseline.CONCLUSIONS: In adult ICU patients receiving RRT at baseline, we observed high incidences of clinically important GI bleeding, but did not observe effects of pantoprazole versus placebo in this subgroup.",
author = "Schefold, {Joerg C} and Mette Krag and S{\o}ren Marker and Anders Perner and J{\o}rn Wetterslev and Wise, {Matt P} and Mark Borthwick and Stepani Bendel and Frederik Keus and Guttormsen, {Anne Berit} and Theis Lange and the SUP-ICU investigators and M{\o}ller, {Morten Hylander}",
note = "{\circledC} 2019 S. Karger AG, Basel.",
year = "2019",
month = "9",
day = "3",
doi = "10.1159/000502732",
language = "English",
volume = "50",
pages = "312--319",
journal = "American Journal of Nephrology",
issn = "0250-8095",
publisher = "S./Karger AG",
number = "4",

}

RIS

TY - JOUR

T1 - Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis

T2 - Results of a Randomized Trial

AU - Schefold, Joerg C

AU - Krag, Mette

AU - Marker, Søren

AU - Perner, Anders

AU - Wetterslev, Jørn

AU - Wise, Matt P

AU - Borthwick, Mark

AU - Bendel, Stepani

AU - Keus, Frederik

AU - Guttormsen, Anne Berit

AU - Lange, Theis

AU - the SUP-ICU investigators

AU - Møller, Morten Hylander

N1 - © 2019 S. Karger AG, Basel.

PY - 2019/9/3

Y1 - 2019/9/3

N2 - BACKGROUND: Intensive care unit (ICU) patients with acute kidney injury requiring renal replacement therapy (RRT) are considered at high risk of gastrointestinal (GI) bleeding and stress ulcer prophylaxis (SUP) is often prescribed. We aimed to assess the incidence of GI bleeding and effects of SUP in these patients.METHODS: We assessed GI bleeding in ICU patients receiving RRT at baseline (and at any time in the ICU) and effects of prophylactic pantoprazole versus placebo in the international SUP in the ICU (SUP-ICU) trial. All analyses were conducted according to a published protocol and statistical analysis plan.RESULTS: Data of 3,291 acutely admitted adult ICU patients with one or more risk factors for GI bleeding randomized to pantoprazole or placebo intravenously once daily during ICU stay (until ICU discharge, death, or a maximum of 90 days) were analyzed. Some 20 out of 258 (7.8%, 95% CI 4.5-11.1%) and 52 out of 568 (9.2%, 95% CI 6.8-11.6%) of the patients receiving RRT at baseline and at any time in ICU, respectively, developed clinically important GI bleeding in the ICU. We did not observe statistically significant differences in the intervention effect (pantoprazole vs. placebo) in the proportion of patients with clinically important GI bleeding, clinically important events, infectious adverse events, use of interventions to stop GI bleeding, or 90-day mortality in patients with versus without RRT at baseline.CONCLUSIONS: In adult ICU patients receiving RRT at baseline, we observed high incidences of clinically important GI bleeding, but did not observe effects of pantoprazole versus placebo in this subgroup.

AB - BACKGROUND: Intensive care unit (ICU) patients with acute kidney injury requiring renal replacement therapy (RRT) are considered at high risk of gastrointestinal (GI) bleeding and stress ulcer prophylaxis (SUP) is often prescribed. We aimed to assess the incidence of GI bleeding and effects of SUP in these patients.METHODS: We assessed GI bleeding in ICU patients receiving RRT at baseline (and at any time in the ICU) and effects of prophylactic pantoprazole versus placebo in the international SUP in the ICU (SUP-ICU) trial. All analyses were conducted according to a published protocol and statistical analysis plan.RESULTS: Data of 3,291 acutely admitted adult ICU patients with one or more risk factors for GI bleeding randomized to pantoprazole or placebo intravenously once daily during ICU stay (until ICU discharge, death, or a maximum of 90 days) were analyzed. Some 20 out of 258 (7.8%, 95% CI 4.5-11.1%) and 52 out of 568 (9.2%, 95% CI 6.8-11.6%) of the patients receiving RRT at baseline and at any time in ICU, respectively, developed clinically important GI bleeding in the ICU. We did not observe statistically significant differences in the intervention effect (pantoprazole vs. placebo) in the proportion of patients with clinically important GI bleeding, clinically important events, infectious adverse events, use of interventions to stop GI bleeding, or 90-day mortality in patients with versus without RRT at baseline.CONCLUSIONS: In adult ICU patients receiving RRT at baseline, we observed high incidences of clinically important GI bleeding, but did not observe effects of pantoprazole versus placebo in this subgroup.

U2 - 10.1159/000502732

DO - 10.1159/000502732

M3 - Journal article

VL - 50

SP - 312

EP - 319

JO - American Journal of Nephrology

JF - American Journal of Nephrology

SN - 0250-8095

IS - 4

ER -

ID: 57911539