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Completed

NCT Number: NCT03453320

Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intensive Care Unit, University Hospital

Linköping, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albumin solution

Drug

Infusion rate and effects

Primary outcomes

  1. 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

  1. Colloid osmotic pressure

    Time frame: 6 hours

    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.

  2. Fluid recruitment from tissues

    Time frame: 6 hours

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Acronym: (RAV)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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