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Albumin Kinetics in Generalized Inflammation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01194492
Enrollment
10
Registered
2010-09-03
Start date
2010-09-30
Completion date
2010-12-31
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Abdominal Surgery

Keywords

plasma albumin, inflammatory reaction, systemic inflammatory response syndrome

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.

Interventions

RADIATIONAlbumin 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.

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Region Stockholm
CollaboratorOTHER_GOV
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in albumin transcapillary escape rate2 daysTranscapillary 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 rate2 days

Secondary

MeasureTime frameDescription
Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP)2 daysThe markers of inflammation is measured twice in each patient, immediately before and two days after surgery, respectively.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026