ClinicalTrials.gg
Not yet recruitingNCT07526220DATACAUSTICUpdated Apr 13, 2026

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

An observational study in Poisoning, sponsored by Société Française d'Anesthésie et de Réanimation. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Société Française d'Anesthésie et de Réanimation · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Poisoning

Browse trials for

03

In context

Poisoning

98 studies on the registry are indexed under Poisoning; 16 are open to participants now.

This study's planned enrollment of 100 is below the median of 122 across 41 observational studies indexed under Poisoning.

Browse Poisoning studies →

Lead sponsor

Société Française d'Anesthésie et de Réanimation is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients admitted in ICU after caustic ingestion in France

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Refus de participer à la recherche
  • Ingestion de caustique ne nécessitant pas une prise en charge en soins critiques
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • observationnal / patients admitted after caustic ingestion in France

    Patients admitted after caustic ingestion in France

    Other: observationnal

Interventions

  • Otherobservationnal

    No intervention / data collection only

06

What researchers measure

Primary outcomes

  1. 1-year mortality

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

    Time frame: 1 year

Secondary outcomes

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

    ICU and hospital mortality

    Time frame: 1 year

  2. Complications and clinical course - mortality at d28

    day-28 mortality

    Time frame: day-28

  3. Complications

    Surgical and medical complications

    Time frame: 1 year

  4. Complications and clinical course - organ support

    Organ support

    Time frame: 1 year

  5. Complications and clinical course - duration of stay

    Length of stay

    Time frame: 1 year

  6. Complications and clinical course

    Late complications/reconstructive surgery

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. 2020 Apr;104(4):708-714. doi: 10.1097/TP.0000000000003137. PubMed 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: 10.1186/s13017-019-0245-2. eCollection 2019. PubMed 31164915 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2026; primary completion for Dec 2026, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2026
First posted
Apr 13, 2026
StartEst.
Apr 15, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jun 30, 2027
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07526220
Lead sponsor
Société Française d'Anesthésie et de Réanimation
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Apr 13, 2026

Study contacts

Benjamin Deniau, MD
Contact
benjdeniau@gmail.com
0142494949
Benjamin Deniau, MD
principal investigator · Hopital Saint Louis - Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion