Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 1:25 PM
Study NCT ID:
NCT01457534
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2011-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-26', 'studyFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2011-10-21', 'lastUpdatePostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'status before operation', 'timeFrame': '1 day before operation', 'description': 'laboratory data(ex : total bilirubin, albumin, coagulation factors, blood gas analysis(arterial CO2 pressure. Blood urea nitrate/Creatinine, Hemoglobin/Hematocrit.)'}, {'measure': 'the amount of ascites', 'timeFrame': 'intraoperative'}, {'measure': 'the duration of anesthesia and operation', 'timeFrame': 'intraoperative'}, {'measure': 'intraoperative hemodynamic instability', 'timeFrame': 'intraoperative'}, {'measure': 'intraoperative bleeding', 'timeFrame': 'intraoperative'}, {'measure': 'Intraoperative urine output', 'timeFrame': 'intraoperative'}, {'measure': 'the types of donation(living or deceased donor)', 'timeFrame': 'intraoperative'}, {'measure': 'survival rate', 'timeFrame': 'on the postoperative 28th days, 365 days'}, {'measure': 'postoperative bleeding amount', 'timeFrame': 'on the postoperative 28th days, 365 days.'}, {'measure': 'postoperative CRRT(continuous renal replacement therapy),', 'timeFrame': 'on the postoperative 28th days, 365days'}, {'measure': 'mortality', 'timeFrame': 'on the postoperative 28th days, 365 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '15954928', 'type': 'BACKGROUND', 'citation': 'Wong LP, Blackley MP, Andreoni KA, Chin H, Falk RJ, Klemmer PJ. Survival of liver transplant candidates with acute renal failure receiving renal replacement therapy. Kidney Int. 2005 Jul;68(1):362-70. doi: 10.1111/j.1523-1755.2005.00408.x.'}, {'pmid': '16429839', 'type': 'BACKGROUND', 'citation': 'Wu CC, Yeung LK, Tsai WS, Tseng CF, Chu P, Huang TY, Lin YF, Lu KC. Incidence and factors predictive of acute renal failure in patients with advanced liver cirrhosis. Clin Nephrol. 2006 Jan;65(1):28-33. doi: 10.5414/cnp65028.'}, {'pmid': '11391230', 'type': 'BACKGROUND', 'citation': 'Gonwa TA, Mai ML, Melton LB, Hays SR, Goldstein RM, Levy MF, Klintmalm GB. Renal replacement therapy and orthotopic liver transplantation: the role of continuous veno-venous hemodialysis. Transplantation. 2001 May 27;71(10):1424-8. doi: 10.1097/00007890-200105270-00012.'}, {'pmid': '8862637', 'type': 'BACKGROUND', 'citation': 'Holt AW, Bierer P, Bersten AD, Bury LK, Vedig AE. Continuous renal replacement therapy in critically ill patients: monitoring circuit function. Anaesth Intensive Care. 1996 Aug;24(4):423-9. doi: 10.1177/0310057X9602400402.'}, {'pmid': '2245605', 'type': 'BACKGROUND', 'citation': 'Matsubara S, Okabe K, Ouchi K, Miyazaki Y, Yajima Y, Suzuki H, Otsuki M, Matsuno S. Continuous removal of middle molecules by hemofiltration in patients with acute liver failure. Crit Care Med. 1990 Dec;18(12):1331-8. doi: 10.1097/00003246-199012000-00005.'}]}, 'descriptionModule': {'briefSummary': 'Background. Acute renal failure after liver transplantation (LT) requiring continuous renal replacement therapy (CRRT) adversely affects patient survival. However, there are few reports to assess the predictors for postoperative CRRT in liver transplant patients. The investigators undertook this study to identify perioperative factors that would predict patients at risk of CRRT.\n\nPatients and Methods. The investigators retrospectively reviewed the data of 148 liver transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18 patients from living and 26 from deceased donors) and those without CRRT was 104. Univariate and stepwise logistic multivariate analyses were performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the data of 148 liver transplant patients from January 2008 to December 2011 at Severance Hospital, Yonsei University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18 patients from living and 26 from deceased donors) and those without CRRT was 104.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19-65 year\n* Liver transplant patients from January 2008 to December 2011\n\nExclusion Criteria:\n\n* Patients treated with CRRT before transplantation'}, 'identificationModule': {'nctId': 'NCT01457534', 'briefTitle': 'The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2010-0671'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'liver transplantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}