Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-02-01 @ 11:06 PM
Study NCT ID:
NCT02718261
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2016-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sup-Icu RENal (SIREN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with clinically important GI bleeding', 'timeFrame': '90 days or length of ICU stay, as applicable'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '90 days or length of ICU stay, as applicable'}, {'measure': 'Proportion of patients with serious adverse reactions', 'timeFrame': '90 days or length of ICU stay, as applicable'}, {'measure': 'Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU', 'timeFrame': '90 days or length of ICU stay, as applicable'}, {'measure': 'Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period', 'timeFrame': '90 days or length of ICU stay, as applicable'}, {'measure': '90-day and 1-year (365 days) mortality post-randomization', 'timeFrame': '90 days/365 days or length of ICU stay, as applicable'}, {'measure': 'Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling).', 'timeFrame': '90 days or length of ICU stay, as applicable'}, {'measure': 'Number of units of packed red blood cells (RBCs) transfused.', 'timeFrame': '90 days or length of ICU stay, as applicable'}, {'measure': '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.', 'timeFrame': '90 day, 360 days, or length of ICU stay, as applicable'}]}, 'conditionsModule': {'conditions': ['Critical Illness', 'Acute Kidney Injury', 'End-stage Renal Disease', 'Renal Replacement Therapy', 'Proton Pump Inhibitor']}, 'referencesModule': {'availIpds': [{'id': 'NCT02467621', 'url': 'https://clinicaltrials.gov/ct2/show/NCT02467621?term=SUP-ICU&rank=1', 'type': 'Study Protocol', 'comment': 'SUP-ICU Website'}], 'references': [{'pmid': '31480045', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29321041', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.sup-icu.com', 'label': 'Homepage SUP-ICU RCT'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* please refer to SUP-ICU (NCT02467621) trial\n\nExclusion Criteria:\n\n* please refer to SUP-ICU (NCT02467621) trial'}, 'identificationModule': {'nctId': 'NCT02718261', 'acronym': 'SIREN', 'briefTitle': 'Sup-Icu RENal (SIREN)', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Sup-Icu RENal (SIREN) - a Sub-analysis of the Prospective SUP (Stress Ulcer Prophylaxis)-ICU Trial on the Risk of GI- Bleeding in ICU Patients Receiving Renal Replacement Therapy', 'orgStudyIdInfo': {'id': 'SIREN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum (pantoprazole)', 'interventionNames': ['Drug: Pantoprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% saline', 'interventionNames': ['Drug: Saline 0.9% (matching placebo)']}], 'interventions': [{'name': 'Pantoprazole', 'type': 'DRUG', 'armGroupLabels': ['Verum (pantoprazole)']}, {'name': 'Saline 0.9% (matching placebo)', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Dept. of Intensive Care Medicine, University of Bern,', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SIREN principle investigator', 'investigatorFullName': 'Jörg Schefold', 'investigatorAffiliation': 'Insel Gruppe AG, University Hospital Bern'}}}}