Albumin Kinetics in Generalized Inflammation
Primary Purpose
Major Abdominal Surgery
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Albumin transcapillary escape rate (125I-albumin)
Sponsored by
About this trial
This is an interventional basic science trial for Major Abdominal Surgery focused on measuring plasma albumin, inflammatory reaction, systemic inflammatory response syndrome
Eligibility Criteria
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
Sites / Locations
- Karolinska University Hosptial, Huddinge
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Albumin kinetics
Arm Description
Outcomes
Primary Outcome Measures
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.
Change from baseline in albumin synthesis rate
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01194492
First Posted
August 31, 2010
Last Updated
January 15, 2021
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT01194492
Brief Title
Albumin Kinetics in Generalized Inflammation
Official Title
Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Region Stockholm
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Abdominal Surgery
Keywords
plasma albumin, inflammatory reaction, systemic inflammatory response syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albumin kinetics
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Albumin transcapillary escape rate (125I-albumin)
Other Intervention Name(s)
SERALB-125
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in albumin transcapillary escape rate
Description
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.
Time Frame
2 days
Title
Change from baseline in albumin synthesis rate
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP)
Description
The markers of inflammation is measured twice in each patient, immediately before and two days after surgery, respectively.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigridur Kalman, MD, Ass Prof
Organizational Affiliation
Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinska University Hosptial, Huddinge
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26313170
Citation
Norberg A, Rooyackers O, Segersvard 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.
Results Reference
result
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Albumin Kinetics in Generalized Inflammation
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