Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects ((RAV))

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.

Study Overview

• Status: Completed
• Conditions: Edema Secondary
• Intervention / Treatment: Drug: Albumin solution

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.

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Intensive Care Unit, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Albumin solution; Infusion rate and effects
Experimental: 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	Drug: Albumin solution; Infusion rate and effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Principal Investigator: Joachim Zdolsek, MD, PhD,Assoc prof, University Hospital, Linkoeping

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: February 24, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 25, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RAV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No