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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002638-35 | EudraCT Number |
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This is a prospective, validation study of a extempore made tracer compared with a commercial. Studies with tracer have no medical effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation.
Primary Objective:
- Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identical values of calculated blood plasma volume and capillary leakage measured as transcapillary escape rate of albumin?
Secondary Objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 123 I-HSA + 125 I-HSA | Active Comparator | Healthy Volunteers, N=16 |
|
| 123 I- HSA + 125 I-HSA | Experimental | Patients, planned for elective Major Abdominal Surgery, N=16 |
|
| 123-I-HSA+125 I-HSA | Experimental | Patients, with a acute pancreatitis or cholecystitis, N=16 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 123 I-HSA + 125 I HSA | Other | Compare and validate the method of measuring albumine turnover rate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transcapillary Escape Rate (TER)of Albumin | Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)? | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional catabolic rate (FCR) | Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| plasma albumin turnover rate | How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups? | 42 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olav Rooyackers, PhDProfessor | Karolinska University Hopsital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital, Huddinge | Stockholm | SE-141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27846908 | Result | Komaromi A, Estenberg U, Hammarqvist F, Rooyackers O, Wernerman J, Norberg A. Simultaneous assessment of the synthesis rate and transcapillary escape rate of albumin in inflammation and surgery. Crit Care. 2016 Nov 15;20(1):370. doi: 10.1186/s13054-016-1536-6. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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3 parallell Groups were measured regarding plasma volume and transcapillary escape rate of albumin where commercial 125I-iodinated human serum albumin was compared to hospital manufactured 123I- iodinated human serum albumin
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