Severity Index of Diquat Poisoning in Evaluating the Prognosis of Acute Diquat Poisoning (SIDP)

July 25, 2022 updated by: Hao Sun, The First Affiliated Hospital with Nanjing Medical University

Development and Validation of Outcome Prediction Models for Acute Diquat Poisoning : a Cohort Study

Diquat (DQ) is a non-selective quick-acting bactericidal herbicide, which is the same bipyridine compound as paraquat (PQ).The number of patients with acute diquat poisoning is gradually increasing worldwide, and the mortality rate is not lower than that of paraquat (citing), but there is currently a lack of objective indicators to assess the severity or prognosis of diquat poisoning.By referring to SIPP ideas, the research team intends to establish a model that meets the clinical characteristics of diquat poisoning and effectively predicts the prognosis of patients, namely SIDP. In order to obtain an objective, accurate and relatively convenient method to judge the condition and prognosis of patients with acute diquat poisoning.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Objective - To develop and validate a set of practical prediction tools that reliably estimate the outcome of acute diquat poisoning（ADP）.

Design - Cohort study with logistic regression analysis to combine predictors and treatment modality.

Main outcome measure - The primary study outcome was death from any cause within 90 days after diquat ingestion.

Goals- To develop a prediction models that reliably estimates the outcome of patients who were managed in various settings for acute diquat poisoning.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

history of diquat exposure

Description

Inclusion Criteria:

  1. all have a clear history of exposure to oral diquat solution;
  2. complete the toxicant test immediately after admission, and have certain initial blood drug concentration data;
  3. the clinical data is true and complete;
  4. the patients or family members are aware of and agree to the treatment plan.

Exclusion Criteria:

  1. ingested two or more toxicants;
  2. diquat was not detected in the blood or urine and the patient has no relevant clinical symptoms;
  3. suffer from primary disease relative to heart, lung, liver, kidney and brain .

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
50 cases are the development set, which is used to develop the prediction model of diquat acute poisoning. These patients are all from the First Affiliated Hospital of Nanjing Medical University.
validation set
50 patients are the validation set, from more than ten tertiary a-level hospitals in the surrounding area, to verify the prediction model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary study outcome was death from any cause within 90 days after diquat ingestion.
Time Frame: 90 days
Through relevant clinical data, find the predictors of death group and survival group
90 days

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, professor, 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)

October 7, 2017

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 1, 2023

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)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstNanjingMU2021ER

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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