Severity Indices of Diquat Poisoning for Triage and Prognosis in Acute Diquat Poisoning (SIDP)

April 16, 2025 updated by: Hao Sun, The First Affiliated Hospital with Nanjing Medical University

Severity Indices of Diquat Poisoning for Triage and Prognosis in Acute Diquat Poisoning: A Multicenter Prospective Cohort Study

To enable emergency physicians to make well-informed triage and treatment decisions, accurate tools to evaluate the severity of diquat poisoning are needed. This study establishes severity indices for diquat poisoning (SIDPs) in assessing the risk of death for patients with acute diquat poisoning for triage purposes and 28-day mortality.

Study Overview

Status

Completed

Conditions

Detailed Description

Self-poisoning with pesticides is a global public health concern, and its effective control is of importance in reducing both morbidity and mortality. In China, poisoning consistently ranked as the fifth leading cause of death from 2009 to 2013, and the overall incidence rate was 39.43/100,000 population in 2019, with intentional poisoning, mostly related to self-harm. Paraquat (1,1'-dimethyl-4,4'-bipyridinium) and, after its ban in China, diquat (1,1'-ethylene-2, 2'-bipyridinium) are the agents with the highest rate of mortality due to their inherent toxicity affecting various organs paired with a lack of effective treatments. As reported from different hospitals, the inhospital case fatality rate of diquat poisoning was 18.6%, whereas the proportion of case fatalities increased to 60% after follow-up in China. Although uncommon, diquat poisoning occurs in many countries, including the United States, where 2,128 cases were identified between 1998 and 2011, and 466 cases were documented in 2023, according to the Annual Report of the National Poison Data System. The lethality of diquat underscores the necessity for precise prognosis. Estimating survival probability empowers physicians to tailor treatment decisions for patients and enhance communication, especially given the variability in capability of emergency departments (EDs) around the world.

Study Type

Observational

Enrollment (Actual)

204

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
        • The First Affiliated Hospital with Nanjing Medical University

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute diquat poisoning

Description

The following criteria were used for patient inclusion:

  1. history of oral exposure to diquat solution reported by patient or proxy;
  2. a specimen for the diquat plasma 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 toxicants in addition to diquat;
  2. diquat was not detected in biological samples;
  3. patients with over half of incomplete information;
  4. patients with an exposure time (time from exposure to presentation at ED) longer than 48 hours.

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

Cohorts and Interventions

Group / Cohort
Development Set
The development set included 106 patients, comprising 67 survivors and 39 fatalities, with a case fatality rate of 36.8%; 56.6% were men. Data from the study center (teaching hospital affiliated to Nanjing Medical University) were used for model development.
External Validation Set
The external validation set included 98 patients, comprised of 69 survivors and 29 fatalities, with a case fatality rate of 29.6%; 61.2% were women. Data from other hospitals (except study center) were used for external validation.

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 includes 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 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

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Chair: Jingsong Zhang, MD, PhD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 13, 2025

Study Registration Dates

First Submitted

January 1, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-SR-394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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