Volume Kinetics for Hyperoncotic Albumin in Burn Patients... | NCT02952378

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

NCT02952378

Sponsor

University Hospital, Linkoeping

Status

Completed

Last Update Posted

May 29, 2019Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Burns

Interventions

Albumins

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Oct 31, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2019

Last Update Posted Date

May 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joachim Zdolsek, MD, PhD, Assoc prof, University Hospital, LinkoepingPrincipal Investigator

Lead Sponsor

University Hospital, LinkoepingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Burn patients	Experimental	Patients with burns exceeding 6-8 Total Burned Surface Area %	Drug: Albumins
Healthy individuals	Experimental	Healthy individuals without allergies.	Drug: Albumins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albumins	Drug	Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.	Burn patients Healthy individuals

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma volume	Plasma volume expansion using hemoglobin as a marker of dilution.	5 hours

Secondary Outcomes

Measure	Description	Time Frame
Colloid osmotic pressure	Effect of hyperoncotic albumin on oncotic pressure.	5 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Zdolsek, MD,PhD,Assoc prof	University Hospital, Linkoeping	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Burn ward, University Hospital, Linköping		Linköping		58185	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39375158	Derived	Hahn RG, Zdolsek M, Gunnstrom M, Hasselgren E, Zdolsek JH. Diuretic responses to Ringer's solution and 20% albumin at different arterial pressures. Physiol Rep. 2024 Oct;12(19):e70069. doi: 10.14814/phy2.70069.
33350618	Derived	Hahn RG, Zdolsek M, Krizhanovskii C, Ntika S, Zdolsek J. Elevated Plasma Concentrations of Syndecan-1 Do Not Correlate With Increased Capillary Leakage of 20% Albumin. Anesth Analg. 2021 Mar 1;132(3):856-865. doi: 10.1213/ANE.0000000000005315.

ID	Term
D000418	Albumins
C525853	galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins