Albumin Kinetics in Generalized Inflammation

Major Abdominal Surgery Clinical Trial

Official title:

Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194492
• Other study ID #: 2010-018529-21
• Status: Completed
• Phase: Phase 4
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the kinetics of endogenous albumin is altered by the generalized inflammation caused by major abdominal surgery.

Description:

Albumin infusions have been used for expansion of the plasma volume for more than 60 years, not only in the operating room, but also in trauma and sepsis. However, there is an ongoing debate whether albumin is good or bad for the patient compared to other intravenous fluids, in different situations. Our research program aims at exploring this issue, starting by describing how the body handles the endogenous albumin in connection with severe inflammation. The final goal is to improve fluid treatment for these patients.

Plasma albumin is often decreased in inflammation. However, the underlying mechanisms are not well described. Two aspects of albumin kinetics will be covered in this study by measurements immediately before and two days after major abdominal surgery, that will serve as a model for generalized inflammation. Albumin fractional synthesis rate will be determined by the incorporation of deuterium labelled phenylalanine into plasma albumin. Albumin distribution will be measured as transcapillary escape rate of radioiodinated albumin. By assessment of P-albumin and plasma volume it will be possible to calculate albumin absolute rate of synthesis and albumin absolute flux from the central compartment, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• written informed consent

• patients planned for major abdominal surgery, pancreatic

• age = 40 years

Exclusion Criteria:

• pregnant or lactating patients

• planned peri-operative infusions of albumin or plasma

• S-creatinine > 110 mmol/L

• allergy against iodine

• other conditions preventing the subject from participating in the study, as judged by the investigator

Related Conditions & MeSH terms

• Inflammation
• Major Abdominal Surgery

Intervention

Radiation:
• Albumin transcapillary escape rate (125I-albumin)
Repeated measure by injection of 0.1 megabecquerel and 0.3 megabecquerel of 125-iodine labeled albumin before surgery and 2 days after surgery, respectively.

Locations

Country	Name	City	State
Sweden	Karolinska University Hosptial, Huddinge	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital, Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Norberg Å, Rooyackers O, Segersvärd R, Wernerman J. Albumin Kinetics in Patients Undergoing Major Abdominal Surgery. PLoS One. 2015 Aug 27;10(8):e0136371. doi: 10.1371/journal.pone.0136371. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in albumin transcapillary escape rate	Transcapillary escape rate is measured as the rate of decrease of 125I-albumin in plasma over 90 min. The assessment is performed twice, immediately before surgery and in the second post-operative day, respectively.	2 days
Primary	Change from baseline in albumin synthesis rate		2 days
Secondary	Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP)	The markers of inflammation is measured twice in each patient, immediately before and two days after surgery, respectively.	2 days