Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the ICU: a Retrospective Analysis

Completed

• Conditions: Nephrogenic Diabetes Insipidus
• Interventions: Drug: Sevoflurane

• Registration Number: NCT04939753
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-27
• Study Start: 2021-05-26
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-25
• Status Verified: 2023-04
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Sevoflurane administration >24h
• 18 years and older

Exclusion Criteria

• < 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sevoflurane group	Sevoflurane	Patients that received sevoflurane while in ICU care.

Primary Outcome Measures

Name	Time	Method
Nephrogenic Diabetes Insipidus prevalence	up to 8 weeks	How many patients under sevoflurane sedation ultimately develop NDI? NDI confirmed by demonstrating the absence of a urine concentrating response to exogenous Arginine Vasopressine.

Secondary Outcome Measures

Name	Time	Method
Number of patients with electrolyte abnormalities as assessed by lab results.	during hospitalization, up to 8 weeks.	Lab results of hematology and chemistry labs show an electrolyte imbalance.
Number of patients with excessive urine output	during hospitalization, up to 8 weeks.	Amount of urine output: \>40 ml/kg/24h
Number of patients with an abnormal physical examination.	during hospitalization, up to 8 weeks.	Typical physical symptoms of (N)DI: tired, lethargic, tachycardia, tachypnea, hypotension and dry mucous membranes.
Number of patients with urine with an abnormal osmolality	during hospitalization, up to 8 weeks.	Lab testing of urine: osmolality \< 300 mosm/kg
Number of patients that show an abnormal amount of fluid intake	during hospitalization, up to 8 weeks.	\>2.5l/day
Number of patients that have an abnormal abdominal echo of the bladder.	during hospitalization, up to 8 weeks.	Echo shows an enlarged bladder.
Number of symptoms of NDI	up to 8 weeks	Number of symptoms of NDI do these patients show?
Timing of symptoms of NDI	up to 8 weeks	After how much time do these patients show symptoms of NDI?
Number of patients that develop risk factors of NDI	up to 8 weeks	Number of patients that develop risk factors (electrolyte disorder, urinary obstruction) for NDI.
Amount of time patient was placed under sevoflurane sedation.	up to 8 weeks	How long are they under sevoflurane sedation.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium