NCT05488262

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

Same day

First QC Date

July 25, 2022

Last Update Submit

June 18, 2024

Conditions

Ketoacidosis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Avicenne

Bobigny, 93000, France

Location

Louis Mourier

Colombes, 92700, France

Location

Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Saint-Louis

Paris, 75012, France

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 4, 2022

Study Start

February 2, 2024

Primary Completion

February 2, 2024

Study Completion

June 14, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)