TY - JOUR
T1 - Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN)
T2 - Study protocol for a pre-planned observational study
AU - Schefold, Joerg C
AU - Perner, Anders
AU - Lange, Theis
AU - Wetterslev, Jørn
AU - Wise, Matt P
AU - Borthwick, Mark
AU - Bendel, Stepani
AU - Keus, Frederik
AU - Guttormsen, Anne Berit
AU - Marker, Søren
AU - Krag, Mette
AU - Møller, Morten Hylander
AU - SUP-ICU investigators
PY - 2018/1/10
Y1 - 2018/1/10
N2 - BACKGROUND: Proton pump inhibitors are often used in critically ill patients to prevent gastrointestinal bleeding despite limited evidence for benefit. Patients with acute kidney injury requiring renal replacement therapy (RRT) are at high risk of gastrointestinal bleeding as (pre-)uremia induces coagulopathy through effects on platelets and coagulation cascades. No high-quality randomized clinical trials have previously assessed the benefits and harms of prophylactic proton pump inhibitor use in this high-risk population of adult critically ill patients.METHODS/DESIGN: Among the 3350 patients included in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial-an investigator-initiated international randomized clinical trial on prophylactic proton pump inhibitor versus placebo in acutely admitted adult ICU patients at risk of gastrointestinal bleeding-we will compare the benefits and harms of prophylactic use of proton pump inhibitor in patients in need of RRT versus those not requiring this treatment. We will determine the proportion of patients with clinically important bleeding, the proportion of patients with adverse events including pneumonia, Clostridium difficile enteritis, or acute myocardial ischemia in the ICU, as well as transfusion requirements. Moreover, 90 day and 365 day mortality post-randomization will be investigated. As a secondary analysis, we will examine the association between acute kidney injury and RRT during ICU stay and gastrointestinal bleeding.DISCUSSION: With the outlined predefined analysis, we will characterize the balance between the benefits and harms of stress ulcer prophylaxis in acutely admitted adult ICU patients in need of RRT, including the potential interaction of allocation to proton pump inhibitor versus placebo.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02718261 . Registered on 14 March 2016.
AB - BACKGROUND: Proton pump inhibitors are often used in critically ill patients to prevent gastrointestinal bleeding despite limited evidence for benefit. Patients with acute kidney injury requiring renal replacement therapy (RRT) are at high risk of gastrointestinal bleeding as (pre-)uremia induces coagulopathy through effects on platelets and coagulation cascades. No high-quality randomized clinical trials have previously assessed the benefits and harms of prophylactic proton pump inhibitor use in this high-risk population of adult critically ill patients.METHODS/DESIGN: Among the 3350 patients included in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial-an investigator-initiated international randomized clinical trial on prophylactic proton pump inhibitor versus placebo in acutely admitted adult ICU patients at risk of gastrointestinal bleeding-we will compare the benefits and harms of prophylactic use of proton pump inhibitor in patients in need of RRT versus those not requiring this treatment. We will determine the proportion of patients with clinically important bleeding, the proportion of patients with adverse events including pneumonia, Clostridium difficile enteritis, or acute myocardial ischemia in the ICU, as well as transfusion requirements. Moreover, 90 day and 365 day mortality post-randomization will be investigated. As a secondary analysis, we will examine the association between acute kidney injury and RRT during ICU stay and gastrointestinal bleeding.DISCUSSION: With the outlined predefined analysis, we will characterize the balance between the benefits and harms of stress ulcer prophylaxis in acutely admitted adult ICU patients in need of RRT, including the potential interaction of allocation to proton pump inhibitor versus placebo.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02718261 . Registered on 14 March 2016.
KW - Acute Kidney Injury/complications
KW - Gastrointestinal Hemorrhage/prevention & control
KW - Humans
KW - Intensive Care Units
KW - Multicenter Studies as Topic
KW - Observational Studies as Topic
KW - Outcome Assessment, Health Care
KW - Peptic Ulcer/prevention & control
KW - Pragmatic Clinical Trials as Topic
KW - Proton Pump Inhibitors/therapeutic use
KW - Renal Replacement Therapy
KW - Stress, Psychological/complications
U2 - 10.1186/s13063-017-2408-3
DO - 10.1186/s13063-017-2408-3
M3 - Article
C2 - 29321041
SN - 1745-6215
VL - 19
SP - 26
JO - Trials
JF - Trials
IS - 1
ER -