Albumin Kinetics in Generalized Inflammation

NCT ID: NCT01194492

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Major Abdominal Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Albumin kinetics

Group Type: OTHER

Albumin transcapillary escape rate (125I-albumin)

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

SERALB-125

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Ake Norberg

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sigridur Kalman, MD, Ass Prof

Role: STUDY_CHAIR

Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology

Locations

Karolinska University Hosptial, Huddinge

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 26313170 (View on PubMed)

Other Identifiers

2010-018529-21

Identifier Type: -

Identifier Source: org_study_id