NCT02556580

Brief Summary

The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the patient is in a post surgical inflammatory state. The study also examines the increase in the plasma colloid osmotic pressure as a result of this infusion and its possible influence on markers of kidney damage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

May 24, 2015

Last Update Submit

March 19, 2018

Conditions

UnconsciousInflammation

Keywords

albuminsurgeryinflammationvolume kinetics

Outcome Measures

Primary Outcomes (1)

  • Degree of plasma volume expansion

    Calculated by volume kinetics

    5 hours

Secondary Outcomes (3)

  • Increase in plasma oncotic pressure

    5 hours

  • Possible effect on biomarkers of kidney injury

    5 hours

  • Half-life of plasma volume expansion

    5 hours

Study Arms (3)

Conscious healthy volunteers

ACTIVE COMPARATOR

Intervention: intravenious infusion Drug: albumin 20%

Drug: Albumin 20%

Surgery under general anesthesia

EXPERIMENTAL

Intervention: intravenious infusion Drug: albumin 20%

Drug: Albumin 20%

Post-surgical inflammation

EXPERIMENTAL

Intervention: intravenious infusion Drug: albumin 20%

Drug: Albumin 20%

Interventions

Albumin 20%DRUG

Intervention: intravenious infusion Drug: albumin

Also known as: Albumin in healthy volunteers
Conscious healthy volunteersPost-surgical inflammationSurgery under general anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers.
  • Patients in ASA classes I-II scheduled for surgery.

You may not qualify if:

  • Expected major hemorrhage during surgery.
  • Blood hemoglobin concentration of \< 10 g/dL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linköping University Hospital

Linköping, 581 85, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, 171 64, Sweden

COMPLETED

Related Publications (4)

  • Hedin A, Hahn RG. Volume expansion and plasma protein clearance during intravenous infusion of 5% albumin and autologous plasma. Clin Sci (Lond). 2005 Mar;108(3):217-24. doi: 10.1042/CS20040303.

    PMID: 15538944BACKGROUND

  • Woodcock TM, Woodcock TE. Revised Starling equation predicts pulmonary edema formation during fluid loading in the critically ill with presumed hypovolemia. Crit Care Med. 2012 Sep;40(9):2741-2; author reply 2742. doi: 10.1097/CCM.0b013e31825ae6c9. No abstract available.

    PMID: 22903119BACKGROUND

  • Wiedermann CJ, Dunzendorfer S, Gaioni LU, Zaraca F, Joannidis M. Hyperoncotic colloids and acute kidney injury: a meta-analysis of randomized trials. Crit Care. 2010;14(5):R191. doi: 10.1186/cc9308. Epub 2010 Oct 28.

    PMID: 21029460BACKGROUND

  • Gunnstrom M, Zdolsek JH, Hahn RG. Plasma Volume Expansion and Fluid Kinetics of 20% Albumin During General Anesthesia and Surgery Lasting for More Than 5 Hours. Anesth Analg. 2022 Jun 1;134(6):1270-1279. doi: 10.1213/ANE.0000000000005802. Epub 2021 Nov 18.

    PMID: 34797221DERIVED

MeSH Terms

Conditions

UnconsciousnessInflammation

Interventions

galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20Albumins

Condition Hierarchy (Ancestors)

Consciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Robert G Hahn, MD, PhD

    Research Director, Södertälje sjukhus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert G Hahn, MD, PhD

CONTACT

0046 8 55024000robert.hahn@sll.se

Joachim Zdolsek, MD, PhD

CONTACT

00456 70 3031434joachim.zdolsek@regionostergotland.se

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Dircetor

Study Record Dates

First Submitted

May 24, 2015

First Posted

September 22, 2015

Study Start

February 1, 2016

Primary Completion

December 31, 2018

Study Completion

April 1, 2019

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

When the study is completed.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data from the volunteer and postoperative patients are available in March 2018. The intraoperative patients are still being recruited
Access Criteria
Contact the Project Leader

Locations

SE(2)