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CompletedNCT04939753Updated Apr 27, 2023

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

An observational study in Nephrogenic Diabetes Insipidus, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Universitair Ziekenhuis Brussel · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Nephrogenic Diabetes Insipidus
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In context

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 374 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sevoflurane administration >24h
  • 18 years and older

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Sevoflurane group

    Patients that received sevoflurane while in ICU care.

    Drug: Sevoflurane

Interventions

  • Sevoflurane administration to sedate the patient

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What researchers measure

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.

    Time frame: up to 8 weeks

Secondary outcomes

  1. Number of patients that develop risk factors of NDI

    Number of patients that develop risk factors (electrolyte disorder, urinary obstruction) for NDI.

    Time frame: up to 8 weeks

  2. Amount of time patient was placed under sevoflurane sedation.

    How long are they under sevoflurane sedation.

    Time frame: up to 8 weeks

  3. Number of patients with electrolyte abnormalities as assessed by lab results.

    Lab results of hematology and chemistry labs show an electrolyte imbalance.

    Time frame: during hospitalization, up to 8 weeks.

  4. Number of patients with excessive urine output

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

    Time frame: during hospitalization, up to 8 weeks.

  5. Number of patients with an abnormal physical examination.

    Typical physical symptoms of (N)DI: tired, lethargic, tachycardia, tachypnea, hypotension and dry mucous membranes.

    Time frame: during hospitalization, up to 8 weeks.

  6. Number of patients with urine with an abnormal osmolality

    Lab testing of urine: osmolality \< 300 mosm/kg

    Time frame: during hospitalization, up to 8 weeks.

  7. Number of patients that show an abnormal amount of fluid intake

    \>2.5l/day

    Time frame: during hospitalization, up to 8 weeks.

  8. Number of patients that have an abnormal abdominal echo of the bladder.

    Echo shows an enlarged bladder.

    Time frame: during hospitalization, up to 8 weeks.

  9. Number of symptoms of NDI

    Number of symptoms of NDI do these patients show?

    Time frame: up to 8 weeks

  10. Timing of symptoms of NDI

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

    Time frame: up to 8 weeks

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Study locations

1 site
  • UZ Brussel
    Jette, Brussels Capital 1090, Belgium
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Apr 2023, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2021
First posted
Jun 25, 2021
StartActual
May 26, 2021
Primary completionActual
Apr 1, 2023
CompletionActual
Apr 1, 2023
Last update
Apr 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04939753
Responsible party
Sponsor
First posted
Jun 25, 2021
Start date
May 26, 2021
Primary completion
Apr 1, 2023
Completion
Apr 1, 2023
Last update
Apr 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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