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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02042599 |
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Date of registration:
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14/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
SEVOKID |
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Scientific title:
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Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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12 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02042599 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Sébastien PERBET |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions
Consent of patients or family Arterial line AKIN score = 3
Exclusion Criteria:
- BMI <30 Sevoflurane anaphylaxia
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Kidney Injury
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Intervention(s)
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Drug: Sedation with sevoflurane during 48-hr in ICU
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Primary Outcome(s)
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Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
[Time Frame: at 5min, 60 min, 24 hrs and just before the end of sedation.]
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Secondary Outcome(s)
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Determination of plasmatic concentrations of HFIP and fluoride
[Time Frame: at 5min, 15 min, 60 min and just before the end of sedation. And 5 min, 10 min, 30 min, 120 min and 360 min after the end of sedation]
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Secondary ID(s)
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2012-005746-37
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CHU-0175
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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