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Clinical Trials/NCT03453320
NCT03453320CompletedPhase 4

Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects

University Hospital, Linkoeping1 site in 1 country12 target enrollmentStarted: February 24, 2018Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Experimental

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

Sponsor
University Hospital, Linkoeping
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joachim Zdolsek

MD, PhD, Assoc prof, consultant

University Hospital, Linkoeping

Study Sites (1)

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