Management in Intensive Care Unit of Life-threatening Keto-Acidosis (MILKA)

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

Study Overview

• Status: Completed
• Conditions: Ketoacidosis

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93000
    • Avicenne
  • Colombes, France, 92700
    • Louis Mourier
  • Le Kremlin-Bicêtre, France, 94270
    • BICETRE
  • Paris, France, 75012
    • Saint-Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: 2022-A00455-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No