Albumin Kinetics in Generalized Inflammation
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|ClinicalTrials.gov Identifier: NCT01194492|
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : January 19, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Major Abdominal Surgery||Radiation: Albumin transcapillary escape rate (125I-albumin)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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
- 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.
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- written informed consent
- patients planned for major abdominal surgery, pancreatic
- age ≥ 40 years
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Responsible Party:||Ake Norberg, MD PhD, Karolinska Institutet|
|Other Study ID Numbers:||
|First Posted:||September 3, 2010 Key Record Dates|
|Last Update Posted:||January 19, 2021|
|Last Verified:||January 2021|
systemic inflammatory response syndrome