Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects

Edema Secondary Clinical Trial

— (RAV)  

Official title:

Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453320
• Other study ID #: RAV
• Status: Completed
• Phase: Phase 4
• Start date: February 24, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema Secondary

Intervention

Drug:
• Albumin solution
Infusion rate and effects

Locations

Country	Name	City	State
Sweden	Intensive Care Unit, University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma volume	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.	6 hours
Secondary	Colloid osmotic pressure	Infusion of hyperoncotic albumin increases the colloid osmotic pressure of plasma. Fluid recruitment from the tissues however diminishes the increase of the colloid osmotic pressure. This effect is measured.	6 hours
Secondary	Fluid recruitment from tissues	The recruitment of fluid from the tissues due to the increase of colloid osmotic pressure is measured. The total recruitment of fluid from the tissues is the sum of the plasma volume dilution and urinary excretion.	6 hours