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

Ketoacidosis Clinical Trial

— MILKA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05488262
• Other study ID #: 2022-A00455-38
• Status: Active, not recruiting
• Start date: February 2, 2024
• Est. completion date: August 2, 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients hospitalized in intensive care between January 2014 and September 2021 for ketoacidosis complicated by organ failure in participating departments.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 2, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major (age = 18 years old)
• Hospitalized in intensive care between January 2014 and September 2021 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

Related Conditions & MeSH terms

• Acidosis
• Ketoacidosis
• Ketosis

Locations

Country	Name	City	State
France	Avicenne	Bobigny
France	Louis Mourier	Colombes
France	Bicêtre	Le Kremlin-Bicêtre
France	Saint-Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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