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

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.

Study Overview

• Status: Completed
• Conditions: Nephrogenic Diabetes Insipidus
• Intervention / Treatment: Drug: Sevoflurane

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sevoflurane group; Patients that received sevoflurane while in ICU care.	Drug: Sevoflurane; Sevoflurane administration to sedate the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Pituitary Diseases; Diabetes Mellitus; Diabetes Insipidus; Diabetes Insipidus, Nephrogenic; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: Sevoflu-DI-IZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No