Nephrogenic Diabetes InsipidusNCT04939753
Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the ICU: a Retrospective Analysis
An observational study of Nephrogenic Diabetes Insipidus, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrogenic Diabetes Insipidus
- What is being tested?
- Sevoflurane
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 26 May 2021to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Sevoflurane administration >24h
- 18 years and older
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the Intensive Care Unit: 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.
- Conditions
- Nephrogenic Diabetes Insipidus
- Being tested
- Sevoflurane
- Medical subject headings
- Diabetes Insipidus, Nephrogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane administration to sedate the patient
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Patients that received sevoflurane while in ICU care. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 weeks
Secondary outcomes (10)
Number of patients that develop risk factors of NDI
Number of patients that develop risk factors (electrolyte disorder, urinary obstruction) for NDI.
Measured: up to 8 weeks
Amount of time patient was placed under sevoflurane sedation.
How long are they under sevoflurane sedation.
Measured: up to 8 weeks
Number of patients with electrolyte abnormalities as assessed by lab results.
Lab results of hematology and chemistry labs show an electrolyte imbalance.
Measured: during hospitalization, up to 8 weeks.
Number of patients with excessive urine output
Amount of urine output: >40 ml/kg/24h
Measured: during hospitalization, up to 8 weeks.
Number of patients with an abnormal physical examination.
Typical physical symptoms of (N)DI: tired, lethargic, tachycardia, tachypnea, hypotension and dry mucous membranes.
Measured: during hospitalization, up to 8 weeks.
Number of patients with urine with an abnormal osmolality
Lab testing of urine: osmolality < 300 mosm/kg
Measured: during hospitalization, up to 8 weeks.
Number of patients that show an abnormal amount of fluid intake
>2.5l/day
Measured: during hospitalization, up to 8 weeks.
Number of patients that have an abnormal abdominal echo of the bladder.
Echo shows an enlarged bladder.
Measured: during hospitalization, up to 8 weeks.
Number of symptoms of NDI
Number of symptoms of NDI do these patients show?
Measured: up to 8 weeks
Timing of symptoms of NDI
After how much time do these patients show symptoms of NDI?
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start26 May 2021
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrogenic Diabetes InsipidusStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939753
- Sponsor's protocol ID
- Sevoflu-DI-IZ
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the Intensive Care Unit: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04939753
- Acronym / sponsor ID
- Sevoflu-DI-IZ
- Conditions
- Nephrogenic Diabetes Insipidus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | – | Drug: SevofluranePatients that received sevoflurane while in ICU care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Sevoflurane administration >24h
- 18 years and older
Key exclusion criteria (7 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneSevoflurane administration to sedate the patient | Drug | Sevoflurane group |
Primary outcome
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.
10 secondary outcomes
Number of patients that develop risk factors of NDI
Time frame: up to 8 weeks
Amount of time patient was placed under sevoflurane sedation.
Time frame: up to 8 weeks
Number of patients with electrolyte abnormalities as assessed by lab results.
Time frame: during hospitalization, up to 8 weeks.
Number of patients with excessive urine output
Time frame: during hospitalization, up to 8 weeks.
Number of patients with an abnormal physical examination.
Time frame: during hospitalization, up to 8 weeks.
Number of patients with urine with an abnormal osmolality
Time frame: during hospitalization, up to 8 weeks.
Number of patients that show an abnormal amount of fluid intake
Time frame: during hospitalization, up to 8 weeks.
Number of patients that have an abnormal abdominal echo of the bladder.
Time frame: during hospitalization, up to 8 weeks.
Number of symptoms of NDI
Time frame: up to 8 weeks
Timing of symptoms of NDI
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrogenic Diabetes Insipidus, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nephrogenic Diabetes Insipidus prevalence (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.