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OpenTrials
Completed

NCT Number: NCT05488262

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avicenne, Bobigny, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. evaluate the incidence of mortality in intensive care units of patients hospitalized for severe diabetic ketoacidosis.

    Time frame: up to 6 months

    Percentage of mortality in intensive care units in patients admitted for ketoacidosis complicated by organ failure.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MILKA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2022
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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