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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2021 |
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Main ID: |
NCT01194492 |
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Date of registration:
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31/08/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Albumin Kinetics in Generalized Inflammation
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Scientific title:
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Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01194492 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Sigridur Kalman, MD, Ass Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet, Institution of Clinical Science Intervention and Technology, Dept of Anesthesiology |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Major Abdominal Surgery
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Intervention(s)
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Radiation: Albumin transcapillary escape rate (125I-albumin)
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Primary Outcome(s)
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Change from baseline in albumin transcapillary escape rate
[Time Frame: 2 days]
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Change from baseline in albumin synthesis rate
[Time Frame: 2 days]
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Secondary Outcome(s)
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Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP)
[Time Frame: 2 days]
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Secondary ID(s)
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2010-018529-21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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