Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-04 @ 8:56 PM
Study NCT ID:
NCT06807151
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leveraging Plasma Concentration Levels to Optimize Extracorporeal Treatment in Acute Diquat Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011041', 'term': 'Poisoning'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015199', 'term': 'Extracorporeal Membrane Oxygenation'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day survival', 'timeFrame': '28 days from the index date', 'description': 'The primary outcome measure included 28-day survival (survived or died).'}, {'measure': 'Time from exposure to death', 'timeFrame': '28 days from the index date', 'description': 'The primary outcome measure included time from exposure to death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diquat', 'poisoning', 'extracorporeal treatment', 'hemoperfusion', 'continuous kidney replacement treatment'], 'conditions': ['Diquat Poisoning', 'Blood Purification']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the clinical value of plasma diquat concentration in guiding personalized extracorporeal treatment regimens for patients with acute diquat poisoning.', 'detailedDescription': 'Diquat (1,1\'-ethylene-2,2\'-bipyridinium) is a bipyridine herbicide with a structure similar to paraquat. Upon ingestion, diquat induces harmful effects on multiple organ sysmtems, including the gastrointestinal, kidney, liver, musculoskeletal, respiratory, cardiovascular, and central nervous systems. Lethal diquat poisoning primarily manifests as severe toxic encephalopathy and circulatory failure, leading to a high mortality rate. Extracorporeal treatment is widely used in cases of diquat poisoning. ECTRs refer to treatments where toxins are removed outside the body, usually through a circuit. Specifically, ECTRs include hemoperfusion (HP), hemodialysis (HD), continuous kidney replacement treatment (CKRT), extended dialysis, peritoneal dialysis (technically intracorporeal), hemofiltration, hemodiafiltration, therapeutic plasma exchange, and albumin/"liver" dialysis. Several studies have demonstrated that HP can significantly reduce plasma paraquat concentrations, and HP is superior than HD in the clearance of diquat. Additionally, clinical case reports have shown that HP, often combined with CKRT, effectively reduces diquat levels and improves clinical outcomes in patients with diquat poisoning. Continuous veno-venous hemodiafiltration (CVVHDF), a type of CKRT, is primarily used for patients with acute kidney injury (AKI) or fluid overload. The primary goal of CVVHDF is to provide continuous kidney support by removing excess fluids and solutes, there by maintaining electrolyte and acid-base balance. AKI, which is a common consequence of diquat poisoning, impairs kidney function and thus reduces the kidney\'s ability to clear diquat formula from the plasma. A study reported an AKI incidence of 73.3% in patients with diquat poisoning, indicating many may need CVVHDF. However, the Extracorporeal Treatments in Poisoning (EXTRIP) workgroup does not provide a definitive recommendation on the use of ECTR for diquat poisoning. Aside from case reports and series, there is a lack of evidence to guide clinicians on the optimal application of ECTR in managing diquat poisoning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute diquat poisoning', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria were:\n\n1. history of oral exposure to diquat solution reported by patient or proxy;\n2. a specimen for the plasma diquat concentration collected immediately upon admission;\n3. documentation that patients or, in case of unconsciousness of the patient, legal proxies were aware of and agreed to treatment plans.\n\nPatients were excluded if:\n\n1. they had ingested other toxins in addition to diquat (qualitative toxicological screening tests);\n2. diquat was not detected in specimens, or plasma concentration data were unavailable;\n3. patients with an exposure time (time from exposure to presentation) longer than 48 hours;\n4. patients had ECTR prior to ED presentation.'}, 'identificationModule': {'nctId': 'NCT06807151', 'briefTitle': 'Leveraging Plasma Concentration Levels to Optimize Extracorporeal Treatment in Acute Diquat Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Leveraging Plasma Concentration Levels to Optimize Extracorporeal Treatment in Acute Diquat Poisoning: A Multi-Center Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2023-SR-849'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extracorporeal Treatment', 'type': 'PROCEDURE', 'description': 'Extracorporeal treatments in our study included hemoperfusion and continuous veno-venous hemodiafiltration.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Chief Physician', 'investigatorFullName': 'Hao Sun', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}