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SIDP: Severity Index of Diquat Poisoning in Evaluating the Prognosis of Acute Diquat Poisoning

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05215457
Collaborator
(none)
100
Enrollment
1
Location
67.8
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development and Validation of Outcome Prediction Models for Acute Diquat Poisoning : a Cohort Study
    Actual Study Start Date :
    Oct 7, 2017
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. The primary study outcome was death from any cause within 90 days after diquat ingestion. [90 days]

      Through relevant clinical data, find the predictors of death group and survival group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu China

    Sponsors and Collaborators

    • The First Affiliated Hospital with Nanjing Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hao Sun, Deputy Director, Institute of Poisoning, Nanjing Medical University, The First Affiliated Hospital with Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT05215457
    Other Study ID Numbers:
    • FirstNanjingMU2021ER
    First Posted:
    Jan 31, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Hao Sun, Deputy Director, Institute of Poisoning, Nanjing Medical University, The First Affiliated Hospital with Nanjing Medical University
    acute diquat poisoning
    predication model
    Additional relevant MeSH terms:
    Poisoning

    Study Results

    No Results Posted as of Jul 27, 2022