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

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ClinicalTrials.gov Identifier: NCT04939753
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Study Description
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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
Nephrogenic Diabetes Insipidus Drug: Sevoflurane

Study Design
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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Groups and Cohorts
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Group/Cohort Intervention/treatment
Sevoflurane group
Patients that received sevoflurane while in ICU care.
 Drug: Sevoflurane
Sevoflurane administration to sedate the patient


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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?


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939753


Contacts
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Contact: Evelien Vandeurzen, Master 024749237 evelien.vandeurzen@uzbrussel.be

Locations
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Belgium
UZ Brussel Recruiting
Jette, Brussel, Belgium, 1090
Contact: Evelien Vandeurzen, Biomedical Sciences    024749237    evelien.vandeurzen@uzbrussel.be   
Principal Investigator: Josia Glissenaar, MD         
Sub-Investigator: Bastiaan Sol, MD         
Sub-Investigator: Bert Bravenboer, MD         
Sub-Investigator: Silke Verheyen, Pharmacist         
Sub-Investigator: Jeroen de Filette, MD         
Sub-Investigator: Jan Poelaert, MD, PhD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
More Information
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04939753    
Other Study ID Numbers: Sevoflu-DI-IZ
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Insipidus
Diabetes Insipidus, Nephrogenic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
 Pituitary Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs