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Completed

NCT Number: NCT01194492

Albumin Kinetics in Generalized Inflammation

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karolinska University Hosptial, Huddinge

Stockholm, SE-141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albumin transcapillary escape rate (125I-albumin)

Radiation

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 names: SERALB-125

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital
  • Region Stockholm

Registry information

Official study title

Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2010
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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