Post operative patients who have been subjected to either a non-emergant Whipple operation or major gynecological cancer surgery ( including resection of ovaries, uterus, adnexa, oment and lymph nodes) and are in need of fluid therapy
Conditions
Interventions
Trade Name: Albumin Behring
Product Name: Albumin
Pharmaceutical Form: Infusion
Trade Name: Albumin
Product Name: Behring
Product Code: 10936
Pharmaceutical Form: Infusion
Sponsors
Skåne University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Elective operation ad modem Whipple or major gynecological cancer surgery. Indication for fluid therapy. Age 40 and above. Written consent to participate. 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: Hypersensitivity to the active drugs. Signs of postoperative bleeding or ongoing drugs with inotropes or vasoconstrictive. The responsible physician considers that there are strong reasons to administrate another fluid or same fluid but in another way or in a different volume than the planned volume. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study compare the plasma volume expanding effect of a rapid administration of 5% albumin to that of a slow administration of 5 % albumin of the same volume. ;Secondary Objective: To study plasma volume over time, changes in heart rate, changes in central venous saturation, changes in Hb, changes in arterial blood pressures, changes in lactate, changes in pulse pressure after “Passive Leg Raising”, in diuresis, changes in central venous pressure, changes in plasma concentration of hormones involved in the regulation of plasma volume, changes in markers of endothelial integrity and to study the incidence of postoperative complications.;Primary end point(s): Change in plasma volume from start of infusion to 3 hours after start of infusion.;Timepoint(s) of evaluation of this end point: 3 hours after start of infusion of albumin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Plasma volume over time, changes in heart rate, changes in central venous saturation, changes in Hb, changes in arterial blood pressures, changes in lactate, changes in pulse pressure after “Passive Leg Raising”, in diuresis, changes in central venous pressure, changes in plasma concentration of hormones involved in the regulation of plasma volume, changes in markers of endothelial integrity and the incidence of postoperative complications.;Timepoint(s) of evaluation of this end point: Repeated bloodsamples and assessments during four hours from start infusion. | — |
Countries
Sweden
Contacts
Public ContactPeter Bentzer
Skåne University Hospital
Outcome results
None listed