Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-29 @ 9:13 AM
Study NCT ID:
NCT04446858
Status:
RECRUITING
Last Update Posted:
2022-05-18
First Post:
2020-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, urine, ascites, stool, DNA, PBMC, Buffi coat'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'up to 10 years', 'description': 'death, liver transplantation'}], 'secondaryOutcomes': [{'measure': 'Ascites', 'timeFrame': 'up to 10 years', 'description': 'Evaluation of amount of ascites according to the Child-Score'}, {'measure': 'Hepatic Encephalopathy', 'timeFrame': 'up to 10 years', 'description': 'Evaluation of the grade according to the West Haven Criteria'}, {'measure': 'Variceal Bleeding', 'timeFrame': 'up to 10 years', 'description': 'Assessment of presence of variceal bleeding'}, {'measure': 'Liver Failure', 'timeFrame': 'up to 10 years', 'description': 'defined as Bilirubin level ≥ 12mg/dl'}, {'measure': 'Acute-on-Chronic Liver Failure', 'timeFrame': 'up to 10 years', 'description': 'Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria'}, {'measure': 'Kidney Failure', 'timeFrame': 'up to 10 years', 'description': 'Assessment of AKI according to KDIGO'}, {'measure': 'Organ Failures', 'timeFrame': 'up to 10 years', 'description': 'Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transjugular intrahepatic portosystemic shunt (TIPS)', 'non-invasive assessments', 'circulating biomarkers', 'Transthoracic echocardiography (TTE) with Speckle-tracking', 'Elastography', 'Contrast-enhanced ultrasound', 'Computer tomography scan (CT-scan)', 'Magnetic resonance imaging (MRI)', 'Urine biomarker'], 'conditions': ['Kidney Failure, Acute']}, 'descriptionModule': {'briefSummary': 'Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.', 'detailedDescription': 'NECTAR consists of patients with ACLF and renal failure with and without receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with portal hypertension and kidney failure are eligible for inclusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with portal hypertension and kidney failure\n\nExclusion Criteria:\n\n* no consent, no kidney failure, no portal hypertension'}, 'identificationModule': {'nctId': 'NCT04446858', 'acronym': 'NECTAR', 'briefTitle': 'Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Non-invasive Evaluation of the Predictive Value of CEUS and SWE in Patients With and Without TIPS With ACLF, Renal Failure and Hepatorenal Syndrome', 'orgStudyIdInfo': {'id': 'NECTAR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With TIPS', 'description': 'Prospective cohort that received TIPS'}, {'label': 'Without TIPS', 'description': 'Prospective cohort that did not receive TIPS'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Praktiknjo, MD', 'role': 'CONTACT', 'email': 'michael.praktiknjo@ukbonn.de', 'phone': '+49228 28715770'}, {'name': 'Johannes Chang, MD', 'role': 'CONTACT', 'email': 'johannes.chang@ukbonn.de', 'phone': '+49228 28715770'}, {'name': 'Nina Böhling, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'centralContacts': [{'name': 'Michael Praktiknjo, MD', 'role': 'CONTACT', 'email': 'michael.praktiknjo@ukbonn.de', 'phone': '+49(0)228-287 15770'}, {'name': 'Johannes Chang, MD', 'role': 'CONTACT', 'email': 'johannes.chang@ukbonn.de', 'phone': '+49(0)228-287 15770'}], 'overallOfficials': [{'name': 'Michael Praktiknjo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bonn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michael Praktiknjo', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}