- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807151
Leveraging Plasma Concentration Levels to Optimize Extracorporeal Treatment in Acute Diquat Poisoning
April 17, 2025 updated by: Hao Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Leveraging Plasma Concentration Levels to Optimize Extracorporeal Treatment in Acute Diquat Poisoning: A Multi-Center Retrospective Cohort Study
This study aimed to evaluate the clinical value of plasma diquat concentration in guiding personalized extracorporeal treatment regimens for patients with acute diquat poisoning.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
163
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210008
- Nanjing Drum Tower Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with acute diquat poisoning
Description
The inclusion criteria were:
- history of oral exposure to diquat solution reported by patient or proxy;
- a specimen for the plasma diquat concentration collected immediately upon admission;
- documentation that patients or, in case of unconsciousness of the patient, legal proxies were aware of and agreed to treatment plans.
Patients were excluded if:
- they had ingested other toxins in addition to diquat (qualitative toxicological screening tests);
- diquat was not detected in specimens, or plasma concentration data were unavailable;
- patients with an exposure time (time from exposure to presentation) longer than 48 hours;
- patients had ECTR prior to ED presentation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
28-day survival
Time Frame: 28 days from the index date
|
The primary outcome measure included 28-day survival (survived or died).
|
28 days from the index date
|
|
Time from exposure to death
Time Frame: 28 days from the index date
|
The primary outcome measure included time from exposure to death.
|
28 days from the index date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
April 12, 2025
Study Registration Dates
First Submitted
January 29, 2025
First Submitted That Met QC Criteria
January 29, 2025
First Posted (Actual)
February 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 22, 2025
Last Update Submitted That Met QC Criteria
April 17, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-SR-849
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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