NCT07526220

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

March 30, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

March 30, 2026

Last Update Submit

April 10, 2026

Conditions

Poisoning

Outcome Measures

Primary Outcomes (1)

  • 1-year mortality

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

    1 year

Secondary Outcomes (6)

  • Complications and clinical course - mortality during hospital/ICU stay

    1 year

  • Complications and clinical course - mortality at d28

    day-28

  • Complications

    1 year

  • Complications and clinical course - organ support

    1 year

  • Complications and clinical course - duration of stay

    1 year

  • +1 more secondary outcomes

Study Arms (1)

observationnal / patients admitted after caustic ingestion in France

Patients admitted after caustic ingestion in France

Other: observationnal

Interventions

observationnalOTHER

No intervention / data collection only

observationnal / patients admitted after caustic ingestion in France

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients admitted in ICU after caustic ingestion in France

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint louis

Paris, 75010, France

Location

Related Publications (8)

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • Hoffman RS, Burns MM, Gosselin S. Ingestion of Caustic Substances. N Engl J Med. 2020;382(18):1739-1748. doi:10.1056/NEJMra1810769

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Poisoning

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Benjamin Deniau, MD

    Hopital Saint Louis - Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Deniau, MD

CONTACT

0142494949benjdeniau@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 13, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

FR(1)