Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects

NCT ID: NCT03453320

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-24
• Study Completion Date: 2019-01-31

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.

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

Conditions

Edema Secondary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Albumin solution

Intervention Type: DRUG

Infusion rate and effects

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

Group Type: EXPERIMENTAL

Albumin solution

Intervention Type: DRUG

Infusion rate and effects

Interventions

Albumin solution

Infusion rate and effects

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Joachim Zdolsek

MD, PhD, Assoc prof, consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim Zdolsek, MD, PhD,Assoc prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Linkoeping

Locations

Intensive Care Unit, University Hospital

Linköping, , Sweden

Countries

Sweden

Other Identifiers

RAV

Identifier Type: -

Identifier Source: org_study_id