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Albumin Kinetics in Generalized Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01194492
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
Karolinska University Hospital
Region Stockholm
Information provided by (Responsible Party):
Ake Norberg, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Radiation: Albumin transcapillary escape rate (125I-albumin) Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Drug Information available for: Albumins

Arms and Interventions
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Arm Intervention/treatment
Albumin kinetics 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Change from baseline in albumin synthesis rate [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska University Hosptial, Huddinge
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Region Stockholm
Investigators
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Study Chair: Sigridur Kalman, MD, Ass Prof Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology
More Information
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Publications of Results:

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Responsible Party: Ake Norberg, MD PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01194492    
Other Study ID Numbers: 2010-018529-21
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Keywords provided by Ake Norberg, Karolinska Institutet:
plasma albumin
inflammatory reaction
systemic inflammatory response syndrome
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes