Albumin Kinetics in Generalized Inflammation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Major Abdominal Surgery

Intervention / Treatment
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* Radiation: Albumin transcapillary escape rate (125I-albumin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Albumin kinetics<br> | Radiation: Albumin transcapillary escape rate (125I-albumin)<br>* 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.<br>* Other names: SERALB-125;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline in albumin synthesis rate |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma albumin, inflammatory reaction, systemic inflammatory response syndrome