Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-06 @ 9:56 AM
Study NCT ID:
NCT03754361
Status:
TERMINATED
Last Update Posted:
2025-06-08
First Post:
2018-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Patient recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'infective morbidity', 'timeFrame': 'At 14 days after the initiation of dialysis', 'description': 'peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)'}], 'secondaryOutcomes': [{'measure': 'Mechanical complications morbidity', 'timeFrame': 'At 14 and 90 days after the initiation of dialysis', 'description': 'catheter leakage and migration (APD), catheter obstruction (IHD)， Exit site bleeding, pneumothorax, hernia'}, {'measure': 'dialysis related mortality', 'timeFrame': 'At 14 and 90 days after the initiation of dialysis', 'description': 'catheter-related:Sepsis, severe thromboembolic events (massive cerebral infarction, pulmonary embolism), arrhythmia (ventricular tachycardia, ventricular fibrillation),bleeding, Congestive heart failure and ischemic heart disease'}, {'measure': 'infective morbidity', 'timeFrame': 'At 90 days after the initiation of dialysis', 'description': 'peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urgent start dialysis', 'automated PD'], 'conditions': ['ESRD']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, controlled clinical trial study. The purpose of this study is to examine the efficacy and safety of automated peritoneal dialysis as compared with intermittent haemodialysis for ESRD patients with indications for urgent start dialysis.', 'detailedDescription': "Hemodialysis（HD） and peritoneal dialysis (PD) are both the main methods to treat with end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and hospitalization rate of new dialysis patient is much higher than that of regular dialysis's. So it is very important to set up dialysis pathway and from inducing dialysis into regular dialysis smoothly. But in the global 50-70%, more than 70% of the patients in China can not establish the dialysis pathway in advance according to the plan. With the common, a temporary deep venous catheter would be used first, then the fistula established later, as the final transition for hemodialysis. Urgent peritoneal dialysis can be established 24 hours after the establishment of permanent access dialysis, simply and easily, it can protect the residual kidney function; reduce treatment costs, hemodynamic stability, no anticoagulant is its unique advantages, At the same time, also avoid the temporary deep venous pathway prone to local bleeding, infection, venous thrombosis, central venous stenosis, direct impact on the future of the mature of fistula , or transplanted kidney vascular conditions. Automatic peritoneal dialysis (APD) in the treatment of urgent dialysis patients can save more manpower and resources, and improve the efficiency of peritoneal dialysis. The study on the efficacy and safety of urgent dialysis lacks the precisely designed multi-center, prospective and controlled clinical trial, and APD only induces 3 days, it is difficult to really reflect the safety and effectiveness of APD. Therefore, it is of great practical significance to study the difference of safety, efficacy and cost-effectiveness between urgent PD and HD in a prospective, control and multicenter clinical trial. 206 ESRD uremia patients will involve in this multi-center, prospective and controlled clinical trial, the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily. All patient will be monitor the physiological and biochemical marker for 14 day, and all adverse events and dead within 90days will collected to evaluated the safety, efficacy of the two urgent dialysis modes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD(chronic kidney disease)-5 stage patient whose eGFR（CKD-EPI（chronic kidney disease-epidemiology collaboration））\\<15 ml/min/1.73m2,occured uremic symptoms or volume overload need of renal replacement therapy(RRT) within 14 days .\n* Prolonged RRT access is not available.\n* No dialysis treatment was given within 1 months.\n* The vital signs are stable and tolerable in peritoneal dialysis catheterization or central venous catheterization.\n* Able to understand the whole process of the trial, voluntarily participate in and sign informed consent.\n\nExclusion Criteria:\n\n* Maintenance RRT alraedy.\n* Serious metabolic disorders ( hyperkalemia and acidosis) cause significant changes in electrocardiogram or other emergency indications to RRT within 24 hours.\n* Hypertensive emergencies(diastolic blood pressure\\>130mmHg)\n* Severe respiratory, circulatory or hepatic failure requires instrumental support or vasoactive drugs to maintain vital signs.\n* High catabolic state eg. severe inflammation or trauma\n* Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (\\<1month), multiple abdominal surgeries.\n* Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure \\<80mmHg).\n* Pregnant.\n* Expected to survive for less than 1 years.\n* Plan for kidney transplantation within 3 months.'}, 'identificationModule': {'nctId': 'NCT03754361', 'acronym': 'URG-APD', 'briefTitle': 'The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Study of Efficacy and Safety of Automated Peritoneal Dialysis in Urgent Start Dialysis as Compared With Intermittent Hemodialysis in ESRD Patients,a Multi-center, Non-blind and Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'URG-APD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APD group', 'description': 'Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment', 'interventionNames': ['Procedure: automated peritoneal dialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IHD group', 'description': 'Subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time.', 'interventionNames': ['Procedure: IHD']}], 'interventions': [{'name': 'automated peritoneal dialysis', 'type': 'PROCEDURE', 'description': 'peritoneal dialysis administered by a cycler', 'armGroupLabels': ['APD group']}, {'name': 'IHD', 'type': 'PROCEDURE', 'description': 'HD 4hour 2-3times per week', 'armGroupLabels': ['IHD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101149', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Luhe Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo No.2 Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'overallOfficials': [{'name': 'Limeng Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, {'name': 'The Luhe Teaching Hospital of the Capital Medical University', 'class': 'OTHER'}, {'name': 'Ningbo No.2 Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}