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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. history of oral exposure to diquat solution reported by patient or proxy;
  2. a specimen for the plasma diquat concentration collected immediately upon admission;
  3. 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:

  1. they had ingested other toxins in addition to diquat (qualitative toxicological screening tests);
  2. diquat was not detected in specimens, or plasma concentration data were unavailable;
  3. patients with an exposure time (time from exposure to presentation) longer than 48 hours;
  4. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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