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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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8 August 2016 |
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Main ID: |
NCT02296294 |
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Date of registration:
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18/11/2014 |
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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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Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy
BCM_Volunteer |
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Scientific title:
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Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02296294 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Austria
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy male volunteers aged between 18 and 50 years
- BMI < 30 kg/m2
- Written informed consent given by volunteers after being provided with detailed
information about the nature, risks, and scope of the clinical study
Exclusion Criteria:
- Implanted pacemaker or defibrillator
- Limb amputation identified by physical examination
- Known allergy or hypersensitivity to Elo-Mel
- Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and
hypertension with a systolic BP > 160 mmHg) after 5 min resting
- Cardiac insufficiency (NYHA= 2)
- Renal insufficiency (GFR = 60 ml/min)
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Fluid Shifts
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Body Fluid Compartments
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Intervention(s)
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Device: Body Composition Monitoring
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Drug: Elo-mel® (Fresenius Kabi Austria)
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Primary Outcome(s)
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Body composition, especially Extracellular Volume, Intracellular Volume, Total Body Fluid Volume and Fluid Overload.
[Time Frame: 6 hours]
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Secondary Outcome(s)
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Change over time of the body fluid compartments after iv fluid therapy
[Time Frame: 6 hours]
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Secondary ID(s)
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BCM Volunteer Study
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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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