Volume Kinetics for 20% Albumin in Different Clinical Situations

Inflammation Clinical Trial

— Albumin  

Official title:

Volume Kinetics for 20% Albumin in Conscious and Anesthetized Humans With and Without Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02556580
• Other study ID #: Albumin April 2015
• Status: Recruiting
• Phase: Phase 4
• First received: May 24, 2015
• Last updated: March 19, 2018
• Start date: February 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: March 2018
• Source: Sodertalje Hospital
• Contact: Robert G Hahn, MD, PhD
• Phone: 0046 8 55024000
• Email: robert.hahn[@]sll.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Unconscious

Intervention

Drug:
• Albumin 20%
Intervention: intravenious infusion Drug: albumin

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Sodertalje Hospital	Karolinska University Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of plasma volume expansion	Calculated by volume kinetics	5 hours
Secondary	Increase in plasma oncotic pressure	Measured by oncometer	5 hours
Secondary	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).	5 hours
Secondary	Half-life of plasma volume expansion	Calculated from the restoration of the diluted blood hemoglobnin concentration	5 hours