Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT05830669
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2023-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Ischemic Preconditioning in Septic Patients
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': 'D018805', 'term': 'Sepsis'}], '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': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Add-on Study (Analysis of further proteins)', 'timeFrame': 'from randomization until 24 hours after randomization'}], 'primaryOutcomes': [{'measure': '1. kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 24h after randomization and [TIMP-2]*[IGFBP7] levels at randomization', 'timeFrame': 'from randomization to 24 hours after randomization'}], 'secondaryOutcomes': [{'measure': 'Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria', 'timeFrame': '72 hours after the onset of sepsis'}, {'measure': 'Severity of AKI', 'timeFrame': '72 hours after the onset of sepsis', 'description': 'The severity for AKI is classified according to the KDIGO criteria'}, {'measure': 'Need for renal replacement therapy', 'timeFrame': '72 hours after the onset of sepsis', 'description': 'Number of patients with renal replacement therapy'}, {'measure': 'Recovery of kidney function', 'timeFrame': 'day 90 after the onset of sepsis', 'description': 'defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine \\>0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent'}, {'measure': 'Mortality', 'timeFrame': 'day 90 after the onset of sepsis'}, {'measure': 'Major adverse kidney events (MAKE) Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more', 'timeFrame': 'day 90 after the onset of sepsis'}, {'measure': 'Length of Intensive Care Unit (ICU) stay', 'timeFrame': 'up to 90 days after onset of sepsis'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 90 days after onset of sepsis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill', 'Acute Kidney Injury', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury is a well-recognized complication in critically ill patients. Up to date there is no clinically established method to reduce the incidence or the severity of acute kidney injury.\n\nRemote ischemic preconditioning (RIPC) will be induced by three cycles of upper limb ischemia.\n\nThe aim of the study is to reduce the incidence of AKI by implementing remote ischemic preconditioning (identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor-binding protein 7(IGFBP7)', 'detailedDescription': 'Acute kidney injury (AKI) is a common complication in critically ill patients with sepsis. To date, there is no pharmacological option to treat or prevent AKI.\n\nIschemic conditioning is an innate tissue adaptation elicited by ischemia that mediates local and remote organ protection against subsequent exposure to the same or other injury.\n\nThe aim of this trial is to evaluate the effects of remote ischemic conditioning in critically ill patients on acute kidney injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age ≥18 years)\n* Critically ill patients with sepsis \\< 12 hours\n* Invasive ventilation for at least 24 hours (propofol-free-sedation) and/or vasopressor therapy\n* Unrestricted intensive care for at least 72 hours\n* Written informed consent\n\nExclusion Criteria:\n\n* Pre-existing AKI\n* (Glomerulo-)nephritis, interstitial nephritis, vasculitis\n* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \\< 30 ml/min/1.73m²\n* Chronic dialysis dependency\n* Kidney transplant in the last 12 months\n* Oral antidiabetics, sulfonamides or nicorandil\n* Pregnancy or breastfeeding\n* Do-not-reanimate order\n* Participation in another interventional trial involving kidney outcomes within the last 3 months\n* Dependency on the investigator or center'}, 'identificationModule': {'nctId': 'NCT05830669', 'acronym': 'RIPC-ICU', 'briefTitle': 'Remote Ischemic Preconditioning in Septic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universität Münster'}, 'officialTitle': 'Effect of Remote Ischemic Preconditioning in Septic Patients on Cell Cycle Arrest Biomarkers - the RIPC-ICU Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AnIt22-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Remote ischemic preconditioning (RIPC) Three Cycles of 5-min upper limb ischemia. If there is no response this will be followed by 2 cycles of 10-min upper-limb ischemia.', 'interventionNames': ['Procedure: Remote ischemic preconditioning (RIPC)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Three cycles of 5- min upper limb sham ischemia.', 'interventionNames': ['Procedure: Sham RIPC']}], 'interventions': [{'name': 'Remote ischemic preconditioning (RIPC)', 'type': 'PROCEDURE', 'description': '3 cycles of 5 min inflation of a blood-pressure cuff to 200 millimetres of mercury (mmHG) (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Sham RIPC', 'type': 'PROCEDURE', 'description': '3 cycles of 5 min inflation of a blood-pressure cuff to 20 mmHG to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Meersch, MD', 'role': 'CONTACT', 'email': 'aki@uni-muenster.de'}], 'facility': 'University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Melanie Meersch-Dini, MD', 'role': 'CONTACT', 'email': 'meersch@uni-muenster.de', 'phone': '+49-251-8347255'}], 'overallOfficials': [{'name': 'Melanie Meersch-Dini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Münster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}