Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-27 @ 1:24 AM
Study NCT ID:
NCT05111535
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stockholm Acute Kidney Injury Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D006947', 'term': 'Hyperkalemia'}], 'ancestors': [{'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': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1861}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2021-09-24', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital outcome', 'timeFrame': 'From admission until discharge or death, assessed for a period of up to 3 months', 'description': 'Death'}, {'measure': '1-year outcome', 'timeFrame': 'From admission until 1 year', 'description': 'Descriptive study on Major Adverse Renal or Cardiovascular Events (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE)'}, {'measure': 'Long-term outcome', 'timeFrame': 'From admission until 10 years', 'description': 'Descriptive study on Major Adverse Renal or Cardiovascular Events (MARCE)'}], 'secondaryOutcomes': [{'measure': 'In-hospital partial renal recovery', 'timeFrame': 'From admission until discharge or death, assessed for a period of up to 3 months', 'description': 'Renal recovery by 30% at the time of discharge or death'}, {'measure': 'In-hospital renal recovery', 'timeFrame': 'From admission until discharge or death, assessed for a period of up to 3 months', 'description': 'Renal recovery by 50% at the time of discharge or death'}, {'measure': 'In-hospital biomarkers', 'timeFrame': 'From previous values or values at admission until discharge or death, assessed for a period of up to 3 months', 'description': 'Changes in biomarkers with focus on potassium, malnutrition, inflammation and acidosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute renal failure', 'hyperkalemia', 'major adverse cardiovascular event'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Since 2009, adult patients with acute kindney injury (AKI) at the department of Nephrology, Danderyd University Hospital and Karolinska Institutet, have been included in a prospective cohort. All patients were treated and evaluated according to a detailed clinical memorandum, and data collected prospectively.\n\nBy 2020, 1861 patiens have been included of which 1519 fulfill current AKI criteria (as defined by KDIGO AKI guidelines) and will be evaluated regarding the following main research questions:\n\n1. Descriptive study on patient characteristics, changes in biomarkers and in-hospital outcome.\n2. One year outcome with focus on renal and cardiovascular outcomes.\n3. Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes.', 'detailedDescription': 'Acure kidney injury (AKI) remains a complex clinical challenge associated with high risk for short-term and long-term adverse events. Since 2009 patients with AKI at the department of Nephrology, Danderyd University Hospital and Karolinska Institutet, have been included in a prospective cohort. Adult patients with either s-creatinine \\>130 micromol/L and previously unknown level, or 30% increase from previous known level were included; patients on dialysis were not included. All patients were treated and evaluated according to a detailed clinical memorandum, and data collected prospectively.\n\nBy 2020, 1861 patiens have been included of which 1519 fulfill current AKI criteria and will be evaluated regarding the following main research questions:\n\n1. Descriptive study on in-hospital outcome (death, renal recovery), patient characteristics, hyperkalemia and changes in biomarkers reflecting inflammation, acidosis and malnutrition.\n2. One year outcome with focus on renal and cardiovascular outcomes (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE).\n3. Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes (MARCE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective observational study, where all patients (aged 18 or above) with AKI admitted to the Department of nephrology at Danderyd University Hospital, Stockholm, Sweden, between 2009 and 2018 were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (one of the following):\n\n* Serum creatinine (sCr) \\>130 µmol/l (1.47 mg/dl) at admission with previously unknown baseline,\n* Increase in sCr by 30% from previous stable out-patient value.\n\nExclusion Criteria:\n\nOngoing dialysis treatment.'}, 'identificationModule': {'nctId': 'NCT05111535', 'acronym': 'SAKIS', 'briefTitle': 'Stockholm Acute Kidney Injury Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'officialTitle': 'Stockholm Prospective Acute Kidney Injury Cohort Study', 'orgStudyIdInfo': {'id': 'SAKIS'}}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Danderyd', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska Institute at Danderyd University Hospital', 'geoPoint': {'lat': 59.40398, 'lon': 18.02376}}, {'zip': '18288', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyd University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Christina Montgomerie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet and Danderyd University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data may be shared, pending application and approval for the specific research question from the Swedish Ethical Review Authority'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jonas Spaak', 'investigatorAffiliation': 'Danderyd Hospital'}}}}