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NCT Number: NCT07526220

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Saint louis

Paris, 75010, France

Location contact

BENJAMIN DENIAU, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observationnal

Other

No intervention / data collection only

Primary outcomes

  1. 1-year mortality

    Time frame: 1 year

    All-cause mortality at 1 year after admission to critical care for caustic ingestion

Secondary outcomes

  1. Complications and clinical course - mortality during hospital/ICU stay

    Time frame: 1 year

    ICU and hospital mortality

  2. Complications and clinical course - mortality at d28

    Time frame: day-28

    day-28 mortality

  3. Complications

    Time frame: 1 year

    Surgical and medical complications

  4. Complications and clinical course - organ support

    Time frame: 1 year

    Organ support

  5. Complications and clinical course - duration of stay

    Time frame: 1 year

    Length of stay

  6. Complications and clinical course

    Time frame: 1 year

    Late complications/reconstructive surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Deniau, MD

CONTACT

[email protected]

0142494949

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Official study title

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

Acronym: DATACAUSTIC

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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