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
|Condition or disease||Intervention/treatment|
|Nephrogenic Diabetes Insipidus||Drug: Sevoflurane|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
Patients that received sevoflurane while in ICU care.
Sevoflurane administration to sedate the patient
- 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.
- 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.
- Amount of time patient was placed under sevoflurane sedation. [ Time Frame: up to 8 weeks ]How long are they under sevoflurane sedation.
- 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.
- Number of patients with excessive urine output [ Time Frame: during hospitalization, up to 8 weeks. ]Amount of urine output: >40 ml/kg/24h
- 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.
- 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
- Number of patients that show an abnormal amount of fluid intake [ Time Frame: during hospitalization, up to 8 weeks. ]>2.5l/day
- 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.
- Number of symptoms of NDI [ Time Frame: up to 8 weeks ]Number of symptoms of NDI do these patients show?
- Timing of symptoms of NDI [ Time Frame: up to 8 weeks ]After how much time do these patients show symptoms of NDI?
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
|Contact: Evelien Vandeurzen, Masteremail@example.com|
|Jette, Brussel, Belgium, 1090|
|Contact: Evelien Vandeurzen, Biomedical Sciences 024749237 firstname.lastname@example.org|
|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|