NCT07526220

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Société Française d'Anesthésie et de Réanimation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Poisoning

Interventions

Type	Name	Description
OTHER	observationnal	No intervention / data collection only

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: France