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Diquat PoisoningNCT05215457

Severity Indices of Diquat Poisoning for Triage and Prognosis in Acute Diquat Poisoning

An observational study of Diquat Poisoning, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Diquat Poisoning
How many people
204 participants
Where
1 siteChina
Study dates
1 Feb 2022to 13 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with acute diquat poisoning

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
diquat, poisoning, triage, prognosis, survival analysis
Medical subject headings
Poisoning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05215457
Study groupRoleWhat they receive
Development SetThe 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 SetThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day survival

    The primary outcome measure includes 28-day survival (survived or died).

    Measured: 28 days from the index date

  2. Time from exposure to death

    The primary outcome included time from exposure to death.

    Measured: 28 days from the index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start1 Feb 2022
  3. Primary completion31 Jul 2023
  4. Study completion13 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05215457
Sponsor's protocol ID
2021-SR-394
Status last verified
Apr 2025
First submitted
1 Jan 2022
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cao ZX, Zhao Y, Gao J, Feng SY, Wu CP, Zhai YZ, Zhang M, Nie S, Li Y. Comparison of severity index and plasma paraquat concentration for predicting survival after paraquat poisoning: A meta-analysis. Medicine (Baltimore). 2020 Feb;99(6):e19063. doi: 10.1097/MD.0000000000019063.

    PubMed 32028427

  • Kim DS, Kang C, Kim DH, Kim SC, Lee SH, Jeong JH, Kang TS, Jung SM, Lee SB, Lee KW, Kim RB. External validation of the prognostic index in acute paraquat poisoning. Hum Exp Toxicol. 2016 Apr;35(4):366-70. doi: 10.1177/0960327115586821. Epub 2015 May 13.

    PubMed 25977258

  • Chen CK, Chen YC, Megarbane B, Yeh YT, Chaou CH, Chang CH, Lin CC. The acute paraquat poisoning mortality (APPM) score to predict the risk of death in paraquat-poisoned patients. Clin Toxicol (Phila). 2022 Apr;60(4):446-450. doi: 10.1080/15563650.2021.1979234. Epub 2021 Sep 20.

    PubMed 34543159

  • Xu S, Hu H, Jiang Z, Tang S, Zhou Y, Sheng J, Chen J, Cao Y. APACHE score, Severity Index of Paraquat Poisoning, and serum lactic acid concentration in the prognosis of paraquat poisoning of Chinese Patients. Pediatr Emerg Care. 2015 Feb;31(2):117-21. doi: 10.1097/PEC.0000000000000351.

    PubMed 25654678

  • Du Y, Mou Y. [Predictive value of 3 methods in severity evaluation and prognosis of acute paraquat poisoning]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2013 Jul;38(7):737-42. doi: 10.3969/j.issn.1672-7347.2013.07.014. Chinese.

    PubMed 23908083

  • Xing J, Chu Z, Han D, Jiang X, Zang X, Liu Y, Gao S, Sun L. Lethal diquat poisoning manifesting as central pontine myelinolysis and acute kidney injury: A case report and literature review. J Int Med Res. 2020 Jul;48(7):300060520943824. doi: 10.1177/0300060520943824.

    PubMed 32734801

  • Magalhaes N, Carvalho F, Dinis-Oliveira RJ. Human and experimental toxicology of diquat poisoning: Toxicokinetics, mechanisms of toxicity, clinical features, and treatment. Hum Exp Toxicol. 2018 Nov;37(11):1131-1160. doi: 10.1177/0960327118765330. Epub 2018 Mar 23.

    PubMed 29569487

  • Oreopoulos DG, McEvoy J. Diquat poisoning. Postgrad Med J. 1969 Sep;45(527):635-7. doi: 10.1136/pgmj.45.527.635. No abstract available.

    PubMed 5809561

  • Cai XL, Teng F, Yu X, Liu LL, Li GQ. [Four cases of acute diquat poisoning with prominent epileptoid seizure and literature review]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2021 May 20;39(5):359-362. doi: 10.3760/cma.j.cn121094-20200224-00078. Chinese.

    PubMed 34074081

  • Yuan G, Li R, Zhao Q, Kong X, Wang Y, Wang X, Guo R. Simultaneous determination of paraquat and diquat in human plasma by HPLC-DAD: Its application in acute poisoning patients induced by these two herbicides. J Clin Lab Anal. 2021 Mar;35(3):e23669. doi: 10.1002/jcla.23669. Epub 2020 Dec 9.

    PubMed 33296104

  • Jones GM, Vale JA. Mechanisms of toxicity, clinical features, and management of diquat poisoning: a review. J Toxicol Clin Toxicol. 2000;38(2):123-8. doi: 10.1081/clt-100100926.

    PubMed 10778908

  • Saeed SA, Wilks MF, Coupe M. Acute diquat poisoning with intracerebral bleeding. Postgrad Med J. 2001 May;77(907):329-32. doi: 10.1136/pmj.77.907.329.

    PubMed 11320278

  • Huang Y, Zhang R, Meng M, Chen D, Deng Y. High-dose diquat poisoning: a case report. J Int Med Res. 2021 Jun;49(6):3000605211026117. doi: 10.1177/03000605211026117.

    PubMed 34182818

Questions about this trial

What is this clinical trial studying?

An observational study of Diquat Poisoning, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day survival (time frame: 28 days from the index date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215457, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.

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