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Completed

NCT Number: NCT04939753

Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the ICU: 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.

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Key information

Conditions

Nephrogenic Diabetes Insipidus Diabetes Insipidus Diabetes Insipidus, Nephrogenic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Sevoflurane administration to sedate the patient

Primary outcomes

  1. Nephrogenic Diabetes Insipidus prevalence

    Time frame: 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 outcomes

  1. Number of patients that develop risk factors of NDI

    Time frame: 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.

    Time frame: up to 8 weeks

    How long are they under sevoflurane sedation.

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

    Time frame: 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

    Time frame: during hospitalization, up to 8 weeks.

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

  5. Number of patients with an abnormal physical examination.

    Time frame: 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

    Time frame: 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

    Time frame: during hospitalization, up to 8 weeks.

    >2.5l/day

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

    Time frame: during hospitalization, up to 8 weeks.

    Echo shows an enlarged bladder.

  9. Number of symptoms of NDI

    Time frame: up to 8 weeks

    Number of symptoms of NDI do these patients show?

  10. Timing of symptoms of NDI

    Time frame: up to 8 weeks

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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 25, 2021
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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