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CompletedNCT07769801ECLAIRUpdated Aug 18, 2026

Comparative Study of Clinical Diagnoses and Autopsy Findings in Intensive Care

An observational study in Autopsy and Autopsy in Intensive Care Unit, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
32
Sex
All
01

Study summary

The objective of this observational study is to compare clinical diagnoses with autopsy and anatomopathological reports of patients who died in the intensive care units of the Nancy University Hospital and the Metz-Thionville Regional Hospital since 2008. This would highlight diagnostic discrepancies that could have influenced patient management and help redefine the role and importance of autopsy in this population.

02

Conditions studied

  • Autopsy
  • Autopsy in Intensive Care Unit

Keywords

  • Autopsy
  • Intensive Care
  • Cause of death
  • Discrepancy
  • Diagnostic error
  • Missed diagnosis
  • Adult
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Systematic recruitment of all patients who died since 2008 at the Nancy University Hospital and the Metz-Thionville Regional Hospital, who had been hospitalized in an intensive care unit and underwent a medico-scientific autopsy.

Inclusion criteria

  • Inclusion of all adult patients who died since 2008 in a department of the Metz-Thionville Regional Hospital or the Nancy University Hospital, who had been admitted to an intensive care unit during the same hospital stay, and who underwent a medico-scientific autopsy followed by an anatomopathological analysis.

Exclusion criteria

Exclusion Criteria:

  • Minor patients
  • Patients who were not admitted to intensive care
  • Forensic autopsies
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
32 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testAutopsy

    Autopsy realised in adult patients during of after a hospitalization in an intensive care unit.

    Also known as: anatomopathological reports

05

What researchers measure

Primary outcomes

  1. Rate of Major Diagnostic Discrepancies (Goldman Class I and II) between Clinical and Autopsy Diagnoses

    Proportion of autopsied ICU patients with a major diagnostic discrepancy (Goldman class I or II) between the antemortem clinical diagnosis and the post-mortem autopsy diagnosis, classified according to the Goldman classification

    Time frame: Diagnoses assessed at time of autopsy, for patients who died in ICU between January 1, 2008 and December 31, 2025

Secondary outcomes

  1. Type and anatomical/etiological category of diagnoses missed clinically and identified at autopsy (Goldman Class I-IV)

    Distribution of missed diagnoses by organ system and etiological category (infectious, vascular, neoplastic, etc.) among discrepancies classified as Goldman class I to IV.

    Time frame: Diagnoses assessed at time of autopsy, for patients who died in ICU between January 1, 2008 and December 31, 2025

  2. Odds Ratios for Patient and Clinical Characteristics Associated With Major Diagnostic Discrepancy (Goldman Class I/II)

    Association between diagnostic discrepancy status (Goldman class I/II vs. class III-VI) and pre-specified patient/clinical characteristics - including age, sex, immunosuppression status, indication for hospitalization, duration of hospital and ICU stay, admission unit, SAPS II score, type of organ failure, presence of septic shock, use of mechanical ventilation, renal replacement therapy, ECMO support, immunosuppressive therapy, and imaging modality - assessed by univariable and multivariable logistic regression, expressed as odds ratios with 95% confidence intervals.

    Time frame: Assessed using clinical data collected from ICU admission to death, for patients who died and underwent autopsy between January 1, 2008 and December 31, 2025

  3. Autopsy Rate Among ICU Deaths

    Proportion of ICU deaths for which an autopsy was performed, calculated as the number of autopsies divided by the total number of deaths occurring after ICU admission, expressed as a percentage

    Time frame: Calculated over the entire study period, from January 1, 2008 to December 31, 2025

  4. Concordance Rate Between Antemortem Imaging Findings and Autopsy/Pathology Findings

    Proportion of cases in which findings from the last antemortem imaging examination (CT, MRI, or ultrasound) performed before death are concordant with autopsy and/or anatomopathological findings. Concordance was assessed qualitatively by investigator review of imaging reports compared with autopsy/pathology reports, and classified as concordant, partially concordant, or discordant, without use of a standardized scoring system.

    Time frame: Assessed at time of autopsy report, for patients who underwent both antemortem imaging and autopsy between January 1, 2008 and December 31, 2025

06

Study locations

1 site
  • Central Hospital, Nancy, France
    Nancy, France
07

Registry details

Key details

Study ID
NCT07769801
Lead sponsor
Central Hospital, Nancy, France
Collaborators
Central Hospital, Metz Thionville, France
Responsible party
Guillaume GAUCHOTTE (Professor, Central Hospital, Nancy, France) — Principal investigator
First posted
Aug 18, 2026
Start date
May 1, 2025
Primary completion
Dec 31, 2025
Completion
Mar 1, 2026
Last update
Aug 18, 2026

Study contacts

Guillaume Louis, MD
principal investigator · Central Hospital, Metz Thionville, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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