A) healthy volunteers (transcapillary escape rate of albumin, plasmavolume, and turnover of albumin) B) Acute inflammation such as pancreatitis or cholecystitis C) Scheduled major abdominal surgery such as pancreatico- duodenectomy in pancreatic cancer
Conditions
Interventions
Trade Name: SERALB-125
Pharmaceutical Form: Solution for injection
Trade Name: Natriumjodid (I-123) Mallinckrodt Medical
Pharmaceutical Form: Solution for injection
Sponsors
Stockholms Läns Landsting, Karolinska Universitetssjukhuset Huddinge, Anestesikliniken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A) INCLUSION CRITERIA VOLUNTEERS - Healthy volunteers, men and women = 40 years - Anticonception for fertile women - Good peripheral blood vessels - Written informed consent B) INCLUSION CRITERIA PATIENTS WITH ACUTE INFLAMMATION - Severe inflammation such as acute pankreatitis or acute cholecystitis - Men and women = 40 years - Written informed consent C) INCLUSION CRITERIA ELECTIVE SURGICAL PATIENTS - Scheduled major abdominal surgery such as pancreatectomy - Men and women = 40 years - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA ALL GROUPS (A-C) - Pregnancy or nursing - Allergy to the investigational medical products - Participation in any other study commencing radiation or stable isotopes within 60 days - Any circumstance that in the judgement of the investigator makes the participation of the volunteer or patient unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identicla values of calculated blood plasma volume and capillary leakage meassured as transcapillary escape rate of albumin? ;Secondary Objective: How do three different meassures of albumin turnover correlatein volunteers? How do the pharmacokinetic parameters of endogenous albumin vary between the three study groups?;Primary end point(s): 1) Transcapillary escape rate for albumin 2) Plasma volume;Timepoint(s) of evaluation of this end point: 1 and 2) Blood sampling for 90 min from isotope injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Plasma albumin (P-albumin) 2) Fractional syntesis rate of albumin (FSR) 3) Fractional catabolic rate for albumin over 24 hours (FCR1, only in volunteers) 4) Fractional catabolic rate meassured over the whole study period (FCR30, onlyu in volunteers) 5) Absolute synthesis rate of albumin (ASR);Timepoint(s) of evaluation of this end point: Same numbers as above 1) All blood samples until 42 dagar (volunteers) or 90+90 min (patients) 2) Blood samples during 90 min after injection of stable isotope 3) Urine collection for 24 hours (day 6, 13, 20) 4) Blood samples up to 42 days 5) Calculated from P-albumin and plasma volume i.e. sampling for 90 min | — |
Countries
Sweden
Contacts
Public ContactEnheten för Anestesi
Karolinska Institutet, Inst CLINTEC
Outcome results
None listed