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Not yet recruiting NCT07526220

Prognostic Factors in Critically Ill Patients Admitted After Caustic Ingestion in France

Observational Poisoning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observationnal.
Who it may be relevant to
Registry conditions: Poisoning. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prognostic Factors in Critically Ill Patients Admitted After Caustic Ingestion in France: a National Retrospective Multicentre Study

Overview

DATACAUSTIC is a national retrospective multicentre observational study designed to identify prognostic factors associated with outcomes in critically ill adult patients admitted after caustic ingestion in France.

Detailed description

Introduction Caustic ingestion in adults is a rare but increasingly frequent medical emergency associated with substantial early morbidity and mortality. Among the most severe cases requiring admission to critical care, short-term mortality is high, and long-term outcomes remain insufficiently characterised. Because individual centres manage only a limited number of such patients, the prognostic factors associated with 1-year mortality, medical and surgical complications, and long-term reconstruction are still poorly defined. The DATACAUSTIC study aims to address this knowledge gap through a national multicentre retrospective analysis of critically ill adult patients admitted after caustic ingestion in France.

Methods DATACAUSTIC is a national, retrospective, multicentre observational study conducted in major French referral centres managing severe caustic ingestions. Adult patients aged 18 years or older admitted to a critical care setting within 72 hours after caustic ingestion between January 2014 and December 2024 will be eligible. Data will be extracted from electronic medical records, hospital discharge reports, and ancillary investigation software. Collected variables will include baseline characteristics, type and estimated quantity of caustic agent, intentionality, co-intoxications, timing of initial management, imaging and endoscopic findings, need for surgery, organ support requirements, biological data from admission to day 7, and in-hospital complications. The primary outcome is 1-year mortality. Secondary outcomes include ICU and hospital mortality, day-28 mortality, infectious, medical and surgical complications, organ failure, tracheotomy, length of stay, oesophageal stenosis, and reconstructive surgery within 1 year. Statistical analyses will include univariable and multivariable regression models, with mixed-effects models used when appropriate to account for repeated measurements and centre-related variability.

Expected Results The study is expected to provide a comprehensive description of the epidemiology, management pathways, and outcomes of critically ill patients with severe caustic ingestion in France. It should identify clinical, radiological, surgical, and biological factors associated with 1-year mortality and other major adverse outcomes. In particular, DATACAUSTIC is expected to improve understanding of early severity markers, the prognostic value of organ failures and supportive therapies, and the burden of long-term digestive and reconstructive sequelae in survivors.

Perspective By generating robust multicentre data in a rare but highly severe condition, DATACAUSTIC may help refine risk stratification, optimise critical care and surgical decision-making, and improve patient pathways from acute management to long-term follow-up. The findings could support future national recommendations, guide the design of prospective studies, and contribute to more standardised management strategies for severe caustic ingestion in critical care.

Interventions

  • Other observationnal
    No intervention / data collection only

Primary outcome measures

  • 1-year mortality [Time frame: 1 year]
Secondary outcome measures (6)
  • Complications and clinical course - mortality during hospital/ICU stay [Time frame: 1 year]
  • Complications and clinical course - mortality at d28 [Time frame: day-28]
  • Complications [Time frame: 1 year]
  • Complications and clinical course - organ support [Time frame: 1 year]
  • Complications and clinical course - duration of stay [Time frame: 1 year]
  • Complications and clinical course [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • age 18 years or older;
  • admission to a critical care unit for caustic ingestion within 72 hours;
  • no opposition to participation/data collection

Exclusion criteria

  • Refus de participer à la recherche
  • Ingestion de caustique ne nécessitant pas une prise en charge en soins critiques

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hopital Saint louis — Paris

Publications

  • Chirica M, Bonavina L, Kelly MD, Sarfati E, Cattan P. Caustic ingestion. Lancet. 2017 May 20;389(10083):2041-2052. doi: 10.1016/S0140-6736(16)30313-0. Epub 2016 Oct 26. PMID 28045663
  • Deniau B, Boulet N, Petrier M, Mezzarobba M, Coutrot M, Cattan P, Corte H, Depret F, Lefrant JY, Plaud B, Boudemaghe T. Epidemiologic features and outcomes associated with caustic ingestion among adults admitted in intensive care unit from 2013 to 2019: a French national observational study. Eur J Trauma Emerg Surg. 2024 Jun;50(3):905-912. doi: 10.1007/s00068-023-02392-9. Epub 2023 Dec 20. PMID 38114647
  • Challine A, Maggiori L, Katsahian S, Corte H, Goere D, Lazzati A, Cattan P, Chirica M. Outcomes Associated With Caustic Ingestion Among Adults in a National Prospective Database in France. JAMA Surg. 2022 Feb 1;157(2):112-119. doi: 10.1001/jamasurg.2021.6368. PMID 34878529
  • Hoffman RS, Burns MM, Gosselin S. Ingestion of Caustic Substances. N Engl J Med. 2020 Apr 30;382(18):1739-1748. doi: 10.1056/NEJMra1810769. No abstract available. PMID 32348645
  • Deniau B, Sabze A, Corte H, Cattan P, Walter T, Depret F, Plaud B. Early- and long-term outcomes of patients admitted to intensive care unit for severe caustic ingestion: a 10-year, retrospective, and cohort study. J Gastrointest Surg. 2024 Dec;28(12):2118-2120. doi: 10.1016/j.gassur.2024.09.016. Epub 2024 Sep 18. No abstract available. PMID 39303903
  • Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available. PMID 18538699
  • Chadban SJ, Ahn C, Axelrod DA, Foster BJ, Kasiske BL, Kher V, Kumar D, Oberbauer R, Pascual J, Pilmore HL, Rodrigue JR, Segev DL, Sheerin NS, Tinckam KJ, Wong G, Balk EM, Gordon CE, Earley A, Rofeberg V, Knoll GA. Summary of the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. Transplantation. 2 PMID 32224812
  • Chirica M, Kelly MD, Siboni S, Aiolfi A, Riva CG, Asti E, Ferrari D, Leppaniemi A, Ten Broek RPG, Brichon PY, Kluger Y, Fraga GP, Frey G, Andreollo NA, Coccolini F, Frattini C, Moore EE, Chiara O, Di Saverio S, Sartelli M, Weber D, Ansaloni L, Biffl W, Corte H, Wani I, Baiocchi G, Cattan P, Catena F, Bonavina L. Esophageal emergencies: WSES guidelines. World J Emerg Surg. 2019 May 31;14:26. doi: 1 PMID 31164915

Identifiers

NCT: NCT07526220 · DATACAUSTIC /

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗