Prognostic Factors in Critically Ill Patients Admitted After Caustic Ingestion in France (DATACAUSTIC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Poisoning
• Intervention / Treatment: Other: observationnal

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Benjamin Deniau, MD; Phone Number: 0142494949; Email: benjdeniau@gmail.com

Study Locations

• France
  • Paris, France, 75010
    • Hopital Saint Louis
    • Contact: BENJAMIN DENIAU, MD; Email: benjdeniau@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients admitted in ICU after caustic ingestion in France

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observationnal / patients admitted after caustic ingestion in France; Patients admitted after caustic ingestion in France	Other: observationnal; No intervention / data collection only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year mortality	All-cause mortality at 1 year after admission to critical care for caustic ingestion	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications and clinical course - mortality during hospital/ICU stay	ICU and hospital mortality	1 year
Complications and clinical course - mortality at d28	day-28 mortality	day-28
Complications	Surgical and medical complications	1 year
Complications and clinical course - organ support	Organ support	1 year
Complications and clinical course - duration of stay	Length of stay	1 year
Complications and clinical course	Late complications/reconstructive surgery	1 year

Collaborators and Investigators

• Sponsor: Société Française d'Anesthésie et de Réanimation
• Investigators: Principal Investigator: Benjamin Deniau, MD, Hopital Saint Louis - Paris

Publications and helpful links

General Publications

• Chirica M, Bonavina L, Kelly MD, Sarfati E, Cattan P. Caustic ingestion. Lancet. 2017;389(10083):2041-2052. doi:10.1016/S0140-6736(16)30313-0
• Deniau B, Boulet N, Pétrier M, et al. 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. Published online December 20, 2023. doi:10.1007/s00068-023-02392-9
• Challine A, Maggiori L, Katsahian S, et al. Outcomes Associated With Caustic Ingestion Among Adults in a National Prospective Database in France. JAMA Surg. 2022;157(2):112-119. doi:10.1001/jamasurg.2021.6368
• Hoffman RS, Burns MM, Gosselin S. Ingestion of Caustic Substances. N Engl J Med. 2020;382(18):1739-1748. doi:10.1056/NEJMra1810769
• Deniau B, Sabze A, Corte H, et al. 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. Published online September 18, 2024:S1091-255X(24)00631-0. doi:10.1016/j.gassur.2024.09.016
• 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. American Journal of Infection Control. 2008;36(5):309-332. doi:10.1016/j.ajic.2008.03.002
• Chadban SJ, Ahn C, Axelrod DA, et al. Summary of the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. Transplantation. 2020;104(4):708-714. doi:10.1097/TP.0000000000003137
• Chirica M, Kelly MD, Siboni S, et al. Esophageal emergencies: WSES guidelines. World J Emerg Surg. 2019;14:26. doi:10.1186/s13017-019-0245-2

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: DATACAUSTIC /

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No