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

Nephrogenic Diabetes Insipidus Clinical Trial

Official title:

Incidence of Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the Intensive Care Unit: a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939753
• Other study ID #: Sevoflu-DI-IZ
• Status: Completed
• Start date: May 26, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Insipidus
• Diabetes Insipidus, Nephrogenic
• Diabetes Mellitus
• Nephrogenic Diabetes Insipidus

Intervention

Drug:
• Sevoflurane
Sevoflurane administration to sedate the patient

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Amount of time patient was placed under sevoflurane sedation.	How long are they under sevoflurane sedation.	up to 8 weeks
Secondary	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.
Secondary	Number of patients with excessive urine output	Amount of urine output: >40 ml/kg/24h	during hospitalization, up to 8 weeks.
Secondary	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.
Secondary	Number of patients with urine with an abnormal osmolality	Lab testing of urine: osmolality < 300 mosm/kg	during hospitalization, up to 8 weeks.
Secondary	Number of patients that show an abnormal amount of fluid intake	>2.5l/day	during hospitalization, up to 8 weeks.
Secondary	Number of patients that have an abnormal abdominal echo of the bladder.	Echo shows an enlarged bladder.	during hospitalization, up to 8 weeks.
Secondary	Number of symptoms of NDI	Number of symptoms of NDI do these patients show?	up to 8 weeks
Secondary	Timing of symptoms of NDI	After how much time do these patients show symptoms of NDI?	up to 8 weeks