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Completed

NCT Number: NCT02952378

Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects

Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately, doubts have been raised about synthetic colloids, and the natural albumin has been used more and more.

One of these solutions is the hyperoncotic "Albumin 20%". However there are still many aspects of the physiological effects of hyperoncotic albumin, that are not known. In this study physiological effects will be studied in burn patients and healthy subjects. The colloid osmotic pressure and the increase of the plasma volume will be measured in 15 healthy subjects and in 15 burn patients. The effect on the plasma volume will be studied using hemoglobin as a marker of dilution. Colloids osmotic pressure and albumin concentration will be measured directly and urin production will also be measured. Blood samples will be collected during 4 to 5 hours to achieve a profile over the changes.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Burn ward, University Hospital, Linköping

Linköping, 58185, Sweden

About this study

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. Patients will also be asked to keep the same rules unless they receive parenteral nutrition. Shortly before the study, the subjects are asked to leave an urine sample.

After 15 minutes of rest the first bood samples are taken. An infusion 3 ml/kg bodyweight Albumin 20% is given during 30 minutes. The first hour after study start (start of infusion) blood samples are taken every 10 minutes. The following 4 hours another 9 blood samples are collected. Hemoglobin, albumin and colloidosmotic pressure will be measured at every occasion.

C-reactive protein, interleukin-6, Syndecan -1 as well as heparan sulfate, will be measured before, after 1 hour and 5 hours after study start.

The total volume of blood collected will be 150 ml. If the study subjects have a low urin output, acetated Ringers will be given at the end of the study. 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

  • For healthy individuals: Healthy, without allergies and with the age of 18 years or above.
  • For patients: Burn injury exceeding 6-8 Total Burned Surface Area %

Exclusion criteria

  • Heart failure
  • Signs of kidney injury/failure
  • Severe allergies

Treatment and study plan

Albumins

Drug

Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.

Other names: Albumin 20%

Primary outcomes

  1. Plasma volume

    Time frame: 5 hours

    Plasma volume expansion using hemoglobin as a marker of dilution.

Secondary outcomes

  1. Colloid osmotic pressure

    Time frame: 5 hours

    Effect of hyperoncotic albumin on oncotic pressure.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Acronym: VAB

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2016
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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