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Volume Kinetics for 20% Albumin in Different Clinical Situations (Albumin)

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ClinicalTrials.gov Identifier: NCT02556580
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
University Hospital, Linkoeping
Karolinska University Hospital
Information provided by (Responsible Party):
Robert Hahn, Sodertalje Hospital

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.

Condition or disease Intervention/treatment Phase
Unconscious Inflammation Drug: Albumin 20% Phase 4

Detailed Description:

15 volunteers, 15 patients undergoing surgery and 15 patients in the post-surgical phase will be recruited for this study because they have different degrees of vasodilatation and inflammation, which are factors of potential importance to the effectiveness of plasma volume expansion with albumin 20%. Hyperoncotic albumin should logically recruit fluid from the interstitial fluid space, but this possibility has recently been questioned in the "revised Starling equation".

The degree of plasma volume expansion and also the half-life will be estimated by population volume kinetics which uses serial analyses of the blood hemoglobin concentration and a summary measure of the excreted urine during the 5-hour experiment to calculate these outcome measures.

There is a risk that hyperoncotic solutions cause pre-renal anuria due to the rise in plasma oncotic pressure. As a safety measure we will assess the plasma oncotic pressure and relevant biomarkers of renal function during the experiments. The experiments will be ended with a slow infusion of 1 L of Ringer´s acetate to dilute any raised oncotic pressure.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Volume Kinetics for 20% Albumin in Conscious and Anesthetized Humans With and Without Inflammation
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 1, 2019

Arm Intervention/treatment
Active Comparator: Conscious healthy volunteers
Intervention: intravenious infusion Drug: albumin 20%
Drug: Albumin 20%
Intervention: intravenious infusion Drug: albumin
Other Name: Albumin in healthy volunteers

Experimental: Surgery under general anesthesia
Intervention: intravenious infusion Drug: albumin 20%
Drug: Albumin 20%
Intervention: intravenious infusion Drug: albumin
Other Name: Albumin in healthy volunteers

Experimental: Post-surgical inflammation
Intervention: intravenious infusion Drug: albumin 20%
Drug: Albumin 20%
Intervention: intravenious infusion Drug: albumin
Other Name: Albumin in healthy volunteers




Primary Outcome Measures :
  1. Degree of plasma volume expansion [ Time Frame: 5 hours ]
    Calculated by volume kinetics


Secondary Outcome Measures :
  1. Increase in plasma oncotic pressure [ Time Frame: 5 hours ]
    Measured by oncometer

  2. Possible effect on biomarkers of kidney injury [ Time Frame: 5 hours ]
    Urinary albumin excretion (unit: mmol of albumin per mmol of urinary creatinine) and urinary neutrophil gelatinase-associated lipocalin (NGAL) excretion (unit: µg/L per mmol of creatinine).

  3. Half-life of plasma volume expansion [ Time Frame: 5 hours ]
    Calculated from the restoration of the diluted blood hemoglobnin concentration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556580


Contacts
Contact: Robert G Hahn, MD, PhD 0046 8 55024000 ext 4670 robert.hahn@sll.se
Contact: Joachim Zdolsek, MD, PhD 00456 70 3031434 joachim.zdolsek@regionostergotland.se

Locations
Sweden
Linköping University Hospital Recruiting
Linköping, Sweden, 581 85
Contact: Joachim Zdolsek, MD, PhD    0046 70 3031434    joachim.zdolsek@regionostergotland.se   
Karolinska University Hospital Completed
Stockholm, Sweden, 171 64
Sponsors and Collaborators
Sodertalje Hospital
University Hospital, Linkoeping
Karolinska University Hospital
Investigators
Principal Investigator: Robert G Hahn, MD, PhD Research Director, Södertälje sjukhus

Publications:
Responsible Party: Robert Hahn, Research Dircetor, Sodertalje Hospital
ClinicalTrials.gov Identifier: NCT02556580     History of Changes
Other Study ID Numbers: Albumin April 2015
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: When the study is completed.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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

Keywords provided by Robert Hahn, Sodertalje Hospital:
albumin
surgery
inflammation
volume kinetics

Additional relevant MeSH terms:
Inflammation
Pathologic Processes