Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the ICU: a Retrospective Analysis
Incidence of Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the Intensive Care Unit: a Retrospective Analysis
1 other identifier
observational
1,000
1 country
1
Brief Summary
The investigators aim to retrospectively explore the electronic medical records of all patients who were admitted to the Intensive Care Unit (ICU) of the UZ Brussels in the last 10 years (March 1st 2011- March 1st 2021) and who received prolonged sedation (\>24h) with sevoflurane.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedStudy Start
First participant enrolled
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 27, 2023
April 1, 2023
1.8 years
April 27, 2021
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Nephrogenic Diabetes Insipidus prevalence
How many patients under sevoflurane sedation ultimately develop NDI? NDI confirmed by demonstrating the absence of a urine concentrating response to exogenous Arginine Vasopressine.
up to 8 weeks
Secondary Outcomes (10)
Number of patients that develop risk factors of NDI
up to 8 weeks
Amount of time patient was placed under sevoflurane sedation.
up to 8 weeks
Number of patients with electrolyte abnormalities as assessed by lab results.
during hospitalization, up to 8 weeks.
Number of patients with excessive urine output
during hospitalization, up to 8 weeks.
Number of patients with an abnormal physical examination.
during hospitalization, up to 8 weeks.
- +5 more secondary outcomes
Study Arms (1)
Sevoflurane group
Patients that received sevoflurane while in ICU care.
Interventions
Eligibility Criteria
all patients who were admitted to the Intensive Care Unit (ICU) of the UZ Brussels in the last 10 years (March 1st 2011- March 1st 2021) and who received prolonged sedation (\>24h) with sevoflurane.
You may qualify if:
- Sevoflurane administration \>24h
- years and older
You may not qualify if:
- \< 18 years old
- Pre-existing diabetes insipidus
- Use of drugs at risk for diabetes insipidus (including lithium, cisplatin)
- Hypercalcemia (persistently \>2.75 mmol/L)
- Pituitary or acute brain surgery
- Patients requiring continuous renal replacement therapy
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel
Jette, Brussels Capital, 1090, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
June 25, 2021
Study Start
May 26, 2021
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
April 27, 2023
Record last verified: 2023-04