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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum (pantoprazole) | Experimental |
| |
| Placebo | Placebo Comparator | 0.9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug |
| ||
| Saline 0.9% (matching placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with clinically important GI bleeding | 90 days or length of ICU stay, as applicable |
| Measure | Description | 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 serious adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark | ||||
| Dept. of Intensive Care Medicine, University of Bern, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31480045 | Derived | Schefold JC, Krag M, Marker S, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Lange T, Moller MH; the SUP-ICU investigators. Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis: Results of a Randomized Trial. Am J Nephrol. 2019;50(4):312-319. doi: 10.1159/000502732. Epub 2019 Sep 3. | |
| 29321041 |
| Label | URL |
|---|---|
| Homepage SUP-ICU RCT | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NCT02467621 | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D058186 | Acute Kidney Injury |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| 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 |
| 90-day and 1-year (365 days) mortality post-randomization | 90 days/365 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 |
| Bern |
| 3010 |
| Switzerland |
| Schefold JC, Perner A, Lange T, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Marker S, Krag M, Moller MH; SUP-ICU investigators. Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study. Trials. 2018 Jan 10;19(1):26. doi: 10.1186/s13063-017-2408-3. |
SUP-ICU Website |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |