Volume Kinetics for 20% Albumin in Different Clinical Situations (Albumin)
Primary Purpose
Unconscious, Inflammation
Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Albumin 20%
Sponsored by
About this trial
This is an interventional basic science trial for Unconscious focused on measuring albumin, surgery, inflammation, volume kinetics
Eligibility 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.
Sites / Locations
- Linköping University HospitalRecruiting
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Conscious healthy volunteers
Surgery under general anesthesia
Post-surgical inflammation
Arm Description
Intervention: intravenious infusion Drug: albumin 20%
Intervention: intravenious infusion Drug: albumin 20%
Intervention: intravenious infusion Drug: albumin 20%
Outcomes
Primary Outcome Measures
Degree of plasma volume expansion
Calculated by volume kinetics
Secondary Outcome Measures
Increase in plasma oncotic pressure
Measured by oncometer
Possible effect on biomarkers of kidney injury
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).
Half-life of plasma volume expansion
Calculated from the restoration of the diluted blood hemoglobnin concentration
Full Information
NCT ID
NCT02556580
First Posted
May 24, 2015
Last Updated
March 19, 2018
Sponsor
Sodertalje Hospital
Collaborators
University Hospital, Linkoeping, Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02556580
Brief Title
Volume Kinetics for 20% Albumin in Different Clinical Situations
Acronym
Albumin
Official Title
Volume Kinetics for 20% Albumin in Conscious and Anesthetized Humans With and Without Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sodertalje Hospital
Collaborators
University Hospital, Linkoeping, Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unconscious, Inflammation
Keywords
albumin, surgery, inflammation, volume kinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conscious healthy volunteers
Arm Type
Active Comparator
Arm Description
Intervention: intravenious infusion Drug: albumin 20%
Arm Title
Surgery under general anesthesia
Arm Type
Experimental
Arm Description
Intervention: intravenious infusion Drug: albumin 20%
Arm Title
Post-surgical inflammation
Arm Type
Experimental
Arm Description
Intervention: intravenious infusion Drug: albumin 20%
Intervention Type
Drug
Intervention Name(s)
Albumin 20%
Other Intervention Name(s)
Albumin in healthy volunteers
Intervention Description
Intervention: intravenious infusion Drug: albumin
Primary Outcome Measure Information:
Title
Degree of plasma volume expansion
Description
Calculated by volume kinetics
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Increase in plasma oncotic pressure
Description
Measured by oncometer
Time Frame
5 hours
Title
Possible effect on biomarkers of kidney injury
Description
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).
Time Frame
5 hours
Title
Half-life of plasma volume expansion
Description
Calculated from the restoration of the diluted blood hemoglobnin concentration
Time Frame
5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert G Hahn, MD, PhD
Phone
0046 8 55024000
Ext
4670
Email
robert.hahn@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Joachim Zdolsek, MD, PhD
Phone
00456 70 3031434
Email
joachim.zdolsek@regionostergotland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Hahn, MD, PhD
Organizational Affiliation
Research Director, Södertälje sjukhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joachim Zdolsek, MD, PhD
Phone
0046 70 3031434
Email
joachim.zdolsek@regionostergotland.se
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
When the study is completed.
IPD Sharing Time Frame
Data from the volunteer and postoperative patients are available in March 2018. The intraoperative patients are still being recruited
IPD Sharing Access Criteria
Contact the Project Leader
Citations:
PubMed Identifier
15538944
Citation
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.
Results Reference
background
PubMed Identifier
22903119
Citation
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.
Results Reference
background
PubMed Identifier
21029460
Citation
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.
Results Reference
background
PubMed Identifier
34797221
Citation
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.
Results Reference
derived
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Volume Kinetics for 20% Albumin in Different Clinical Situations
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