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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT04939753
Collaborator
(none)
1,000
1
11.2
89.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Incidence of Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the Intensive Care Unit: a Retrospective Analysis
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Sevoflurane group

Patients that received sevoflurane while in ICU care.

Drug: Sevoflurane
Sevoflurane administration to sedate the patient

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Amount of time patient was placed under sevoflurane sedation. [up to 8 weeks]

    How long are they under sevoflurane sedation.

  3. 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.

  4. Number of patients with excessive urine output [during hospitalization, up to 8 weeks.]

    Amount of urine output: >40 ml/kg/24h

  5. 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.

  6. Number of patients with urine with an abnormal osmolality [during hospitalization, up to 8 weeks.]

    Lab testing of urine: osmolality < 300 mosm/kg

  7. Number of patients that show an abnormal amount of fluid intake [during hospitalization, up to 8 weeks.]

    >2.5l/day

  8. Number of patients that have an abnormal abdominal echo of the bladder. [during hospitalization, up to 8 weeks.]

    Echo shows an enlarged bladder.

  9. Number of symptoms of NDI [up to 8 weeks]

    Number of symptoms of NDI do these patients show?

  10. Timing of symptoms of NDI [up to 8 weeks]

    After how much time do these patients show symptoms of NDI?

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Brussel Jette Brussel Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT04939753
Other Study ID Numbers:
  • Sevoflu-DI-IZ
First Posted:
Jun 25, 2021
Last Update Posted:
Nov 9, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021