Albumin Kinetics in Generalized Inflammation
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Abdominal Surgery |
Radiation: Albumin transcapillary escape rate (125I-albumin) |
Phase 4 |
| Study Type: | Interventional |
| 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, B-LPK, and P-CRP) [ Time Frame: 2 days ] [ Designated as safety issue: No ]The markers of inflammation is measured twice in each patient, immediately before and two days after surgery, respectively.
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Albumin kinetics |
Radiation: Albumin transcapillary escape rate (125I-albumin)
Repeated measure by injection of 0.1 MBq and 0.3 MBq of 125-iodine labeled albumin before surgery and 2 days after surgery, respectively.
Other Name: SERALB-125
|
Detailed 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 [2H5]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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Åke Norberg, MD, PhD | +46 8 58 58 51 59 | ake.norberg@karolinska.se |
| Sweden | |
| Karolinska University Hosptial, Huddinge | Recruiting |
| Stockholm, Sweden, SE-141 86 | |
| Contact: Åke Norberg, MD, PhD +46 8 58 58 51 59 ake.norberg@karolinska.se | |
| Principal Investigator: Åke Norberg, MD, PhD | |
| Study Chair: | Sigridur Kalman, MD, Ass Prof | Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology |
More Information
No publications provided
| Responsible Party: | Åke Norberg, M.D., Ph.D., Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT01194492 History of Changes |
| Other Study ID Numbers: | 2010-018529-21 |
| Study First Received: | August 31, 2010 |
| Last Updated: | September 10, 2010 |
| Health Authority: | Sweden: Medical Products Agency Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
plasma albumin inflammatory reaction systemic inflammatory response syndrome |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013