Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Plasma volume
Study Overview
Brief Summary
Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.
One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.
In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.
Detailed Description
Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.
Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.
Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.
After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).
During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy, without allergies and with the age 18 years or above
Exclusion Criteria
- •Heart failure
- •Signs of kidney injury/failure
- •Severe allergies
- •Pregnancy
Arms & Interventions
Rapid - Slow
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between.
First time rapid (30 minutes), second time slow (120 minutes). Albumin solution
Intervention: Albumin solution (Drug)
Slow - Rapid
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between.
First time rapid (120 minutes), second time slow (30 minutes). Albumin solution
Intervention: Albumin solution (Drug)
Outcomes
Primary Outcomes
Plasma volume
Time Frame: 6 hours
Albumin infusion expands the plasma volume and dilutes hemoglobin. The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.
Secondary Outcomes
- Colloid osmotic pressure(6 hours)
- Fluid recruitment from tissues(6 hours)
Investigators
Joachim Zdolsek
MD, PhD, Assoc prof, consultant
University Hospital, Linkoeping