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临床试验/NCT07526220
NCT07526220尚未招募不适用

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

Société Française d'Anesthésie et de Réanimation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1-year mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

observationnal / patients admitted after caustic ingestion in France

Patients admitted after caustic ingestion in France

干预措施: observationnal (Other)

结局指标

主要结局

1-year mortality

时间窗: 1 year

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

次要结局

  • Complications and clinical course - duration of stay(1 year)
  • Complications and clinical course(1 year)
  • 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)

研究者

发起方
Société Française d'Anesthésie et de Réanimation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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