PoisoningDATACAUSTICNCT07526220
Prognostic Factors in Critically Ill Patients Admitted After Caustic Ingestion in France
An observational study of Poisoning, run by Société Française d'Anesthésie et de Réanimation at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poisoning
- What is being tested?
- observationnal
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted in ICU after caustic ingestion in France
Who may be able to join
- age 18 years or older;
- admission to a critical care unit for caustic ingestion within 72 hours;
- no opposition to participation/data collection
Who cannot join
- Refus de participer à la recherche
- Ingestion de caustique ne nécessitant pas une prise en charge en soins critiques
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital Saint louis
Paris, 75010
BENJAMIN DENIAU, MD, benjdeniau@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Poisoning
- Being tested
- observationnal
- Medical subject headings
- Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationnalOther
No intervention / data collection only
| Study group | Role | What they receive |
|---|---|---|
| observationnal / patients admitted after caustic ingestion in France | Patients admitted after caustic ingestion in France Receives: Other: observationnal |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year mortality
All-cause mortality at 1 year after admission to critical care for caustic ingestion
Measured: 1 year
Secondary outcomes (6)
Complications and clinical course - mortality during hospital/ICU stay
ICU and hospital mortality
Measured: 1 year
Complications and clinical course - mortality at d28
day-28 mortality
Measured: day-28
Complications
Surgical and medical complications
Measured: 1 year
Complications and clinical course - organ support
Organ support
Measured: 1 year
Complications and clinical course - duration of stay
Length of stay
Measured: 1 year
Complications and clinical course
Late complications/reconstructive surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Deniau, MD, Principal investigator, Hopital Saint Louis - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526220
- Sponsor's protocol ID
- DATACAUSTIC /
- Acronym
- DATACAUSTIC
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 28045663Deniau 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 38114647Challine 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 34878529Hoffman 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 32348645Deniau 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 39303903Horan 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 18538699Chadban 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 32224812Chirica 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors in Critically Ill Patients Admitted After Caustic Ingestion in France: a National Retrospective Multicentre Study
- ClinicalTrials.gov ID
- NCT07526220
- Acronym / sponsor ID
- DATACAUSTIC / DATACAUSTIC /
- Conditions
- Poisoning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observationnal / patients admitted after caustic ingestion in France | – | Other: observationnalPatients admitted after caustic ingestion in France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted in ICU after caustic ingestion in France
Key inclusion criteria (3 listed)
- age 18 years or older;
- admission to a critical care unit for caustic ingestion within 72 hours;
- no opposition to participation/data collection
Key exclusion criteria (2 listed)
- Refus de participer à la recherche
- Ingestion de caustique ne nécessitant pas une prise en charge en soins critiques
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationnalNo intervention / data collection only | Other | observationnal / patients admitted after caustic ingestion in France |
Primary outcome
1-year mortality
Time frame: 1 year
All-cause mortality at 1 year after admission to critical care for caustic ingestion
6 secondary outcomes
Complications and clinical course - mortality during hospital/ICU stay
Time frame: 1 year
Complications and clinical course - mortality at d28
Time frame: day-28
Complications
Time frame: 1 year
Complications and clinical course - organ support
Time frame: 1 year
Complications and clinical course - duration of stay
Time frame: 1 year
Complications and clinical course
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 28045663Chirica 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.
- Background: PubMed 38114647Deniau 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.
- Background: PubMed 34878529Challine 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.
- Background: PubMed 32348645Hoffman 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.
- Background: PubMed 39303903Deniau 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.
- Background: PubMed 18538699Horan 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.
- Background: PubMed 32224812Chadban 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.
- Background: PubMed 31164915Chirica 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Deniau, MD principal investigator
Hopital Saint Louis - Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poisoning, run by Société Française d'Anesthésie et de Réanimation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Deniau, MD (0142494949, benjdeniau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07526220, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.