Albumin Kinetics in Generalized Inflammation
|Major Abdominal Surgery||Radiation: Albumin transcapillary escape rate (125I-albumin)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery|
- Change from baseline in albumin transcapillary escape rate [ Time Frame: 2 days ]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.
- Change from baseline in albumin synthesis rate [ Time Frame: 2 days ]
- Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP) [ Time Frame: 2 days ]The markers of inflammation is measured twice in each patient, immediately before and two days after surgery, respectively.
|Study Start Date:||September 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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.
Other Name: SERALB-125
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194492
|Karolinska University Hosptial, Huddinge|
|Stockholm, Sweden, SE-141 86|
|Study Chair:||Sigridur Kalman, MD, Ass Prof||Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology|