Acute Kidney Injury, Critical Illness, End-stage Renal Disease, Proton Pump Inhibitor, Renal Replacement Therapy
Conditions
Brief summary
Data show that episodes of bleeding may often be observed in critically ill patients with dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease (ESRD) may be considered a high risk population in regard to e.g. development of gastrointestinal (GI-) bleeding. In the current prospective subanalysis SIREN of the randomized placebo-controlled clinical trial SUP-ICU (NCT02467621), the investigators seek to elucidate whether the subpopulation of critically ill patients with acute kidney injury requiring renal replacement therapy (RRT) benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.
Interventions
DRUGPantoprazole
DRUGSaline 0.9% (matching placebo)
Sponsors
Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* please refer to SUP-ICU (NCT02467621) trial
Exclusion criteria
* please refer to SUP-ICU (NCT02467621) trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with clinically important GI bleeding | 90 days or length of ICU stay, as applicable |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with one or more of the following adverse events: clinically important GI bleeding, pneumonia, C. difficile infection, or acute myocardial ischemia in the ICU | 90 days or length of ICU stay, as applicable |
| Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU | 90 days or length of ICU stay, as applicable |
| Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period | 90 days or length of ICU stay, as applicable |
| Proportion of patients with serious adverse reactions | 90 days or length of ICU stay, as applicable |
| Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling). | 90 days or length of ICU stay, as applicable |
| Number of units of packed red blood cells (RBCs) transfused. | 90 days or length of ICU stay, as applicable |
| 90-day/360-day/ ICU mortality rate in RRT group vs. ESRD group vs. RRT at any time on the ICU vs. control group incl. analysis of verum/ placebo subgroups. | 90 day, 360 days, or length of ICU stay, as applicable |
| 90-day and 1-year (365 days) mortality post-randomization | 90 days/365 days or length of ICU stay, as applicable |
Countries
Denmark, Switzerland
Outcome results
None listed