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Albumin Kinetics in Generalized Inflammation

This study has been completed.
Sponsor:
Collaborators:
Karolinska University Hospital
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Ake Norberg, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01194492
First received: August 31, 2010
Last updated: February 17, 2014
Last verified: February 2014
  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

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, 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.


Enrollment: 10
Study Start Date: September 2010
Study Completion Date: March 2011
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 megabecquerel and 0.3 megabecquerel 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 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194492

Locations
Sweden
Karolinska University Hosptial, Huddinge
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Stockholm County Council, Sweden
Investigators
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: Ake Norberg, MD PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01194492     History of Changes
Other Study ID Numbers: 2010-018529-21
Study First Received: August 31, 2010
Last Updated: February 17, 2014
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 November 20, 2014