Albumin Kinetics in Generalized Inflammation
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 19, 2021
January 1, 2021
3 months
August 31, 2010
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in albumin transcapillary escape rate
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 days
Change from baseline in albumin synthesis rate
2 days
Secondary Outcomes (1)
Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP)
2 days
Study Arms (1)
Albumin kinetics
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- written informed consent
- patients planned for major abdominal surgery, pancreatic
- age ≥ 40 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
- Region Stockholmcollaborator
Study Sites (1)
Karolinska University Hosptial, Huddinge
Stockholm, SE-141 86, Sweden
Related Publications (1)
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.
PMID: 26313170RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sigridur Kalman, MD, Ass Prof
Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 3, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 19, 2021
Record last verified: 2021-01