KetoacidosisMILKANCT05488262
Management in Intensive Care Unit of Life-threatening Keto-Acidosis
An observational study of Ketoacidosis, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Patients hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in participating departments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ketoacidosis
- How many people
- 70 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Feb 2024to 14 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in participating departments.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Avicenne
Bobigny, 93000
Louis Mourier
Colombes, 92700
Bicêtre
Le Kremlin-Bicêtre, 94270
Saint-Louis
Paris, 75012
About this study
Patients hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in participating departments.
Read the 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
- Conditions
- Ketoacidosis
- Medical subject headings
- Ketosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start2 Feb 2024
- Primary completion2 Feb 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetoacidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488262
- Sponsor's protocol ID
- 2022-A00455-38
- Acronym
- MILKA
- Status last verified
- Jun 2024
- First submitted
- 25 Jul 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management in Intensive Care Unit of Life-threatening Keto-Acidosis
- ClinicalTrials.gov ID
- NCT05488262
- Acronym / sponsor ID
- MILKA / 2022-A00455-38
- Conditions
- Ketoacidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in intensive care between January 2014 and December 2023 for ketoacidosis complicated by organ failure in participating departments.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ketoacidosis, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the incidence of mortality in intensive care units of patients hospitalized for severe diabetic ketoacidosis. (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.