Management in Intensive Care Unit of Life-threatening Keto-Acidosis

Completed

• Conditions: Ketoacidosis

• Registration Number: NCT05488262
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Patients hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in participating departments.

Detailed Description

Analysis of patients with International Statistical Classification of Diseases and Related Health Problems coding compatible with inclusion

* Selection of patients eligible for inclusion based on review of medical records (verification of inclusion and non-inclusion criteria)

* Telephone contact and sending of the information letter on participation in the study and research of the patient's non-opposition to his participation and the processing of his data.

* Collection of retrospective data

* Phone call to collect prospective data

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2024-02-02
• Primary Completion: 2024-02-02
• Status Verified: 2024-06
• Study Completion: 2024-06-14
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Major (age ≥ 18 years old)
• Hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in the participating departments.
• Diagnosis of ketoacidosis judged to be the main cause of the severity of the clinical condition.
• Blood potential hydrogen < 7.15 and bicarbonates < 10mmol/L in the first 12 hours of treatment.
• Presenting at least one of the 3 organ failures during hospitalization among:
• Use of extra-renal purification for acute renal failure
• Administration of pressor amines
• Use of mechanical ventilation

Exclusion Criteria

• Metabolic acidosis primarily of an origin other than ketonic
• Refusal to participate or opposition to the processing of their data
• Patient under guardianship or curators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluate the incidence of mortality in intensive care units of patients hospitalized for severe diabetic ketoacidosis.	up to 6 months	Percentage of mortality in intensive care units in patients admitted for ketoacidosis complicated by organ failure.

Trial Locations

Locations (4)

Saint-Louis; 🇫🇷 Paris, France

Avicenne; 🇫🇷 Bobigny, France

Louis Mourier; 🇫🇷 Colombes, France

Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France