Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-26 @ 4:30 PM
Study NCT ID:
NCT03720860
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Mediators of Acute Kidney Injury in Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum Blood Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histones', 'timeFrame': 'Within 1 month', 'description': 'Correlation between levels of histones and degree of acute kidney injury'}], 'secondaryOutcomes': [{'measure': 'Other inflammtory mediators', 'timeFrame': 'Within 1 month', 'description': 'Correlation between levels of other inflammtory mediators and degree of acute kidney injury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Surgery', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) affects more than 50% of patients admitted to the intensive care unit. The most common underlying cause is sepsis. Severe AKI in combination with sepsis is associated with high mortality. The mechanisms for sepsis-induced AKI are largely unknown. Our hypothesis is that the inflammatory response to an infection cause collateral damage to host tissue and contributes to the development of AKI. In this study we want to investigate the presence of novel inflammatory mediators in patients with sepsis, patients subjected to major surgery (sterile inflammation) and non-inflamed patients and correlate their levels with the risk for AKI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients subjected to major surgery or intensive care', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients admitted to the intensive/post operative care unit\n\n* with septic shock or\n* post major surgery or\n* after intoxication with a chemical compund\n\nExclusion Criteria:\n\n* Pregnancy or\n* Breast feeding or\n* Chronic kidney disease or\n* intoxication with nephrotoxic compund or\n* lack of informed consent'}, 'identificationModule': {'nctId': 'NCT03720860', 'acronym': 'PronMed', 'briefTitle': 'Inflammatory Mediators of Acute Kidney Injury in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Prospective Studie of Inflammatory Markers in Urine, Plasma and Sputum Associated With Acute Kidney Injury', 'orgStudyIdInfo': {'id': '2017-043PronMed'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis', 'description': 'Patients admitted to the intensive care unit with sepsis'}, {'label': 'Surgery', 'description': 'Patinets subjected to major surgery and then admitted to the intensive care unit'}, {'label': 'Non-inflamed', 'description': 'Otherwise healthy patients admitted to the intensive care unit because of intoxication.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Robert Frithiof, MD PhD', 'role': 'CONTACT', 'email': 'robert.frithiof@surgsci.uu.se', 'phone': '0736563473'}, {'name': 'Sara Bulow, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Akademiska sjukhuset, Centraloperation', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Sara Bulow, MD', 'role': 'CONTACT', 'email': 'sara.bulow.anderberg@akademiska.se', 'phone': '+46730247414'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maastricht University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Robert Frithiof', 'investigatorAffiliation': 'Uppsala University'}}}}