THE IMPORTANCE OF ALBUMIN INFUSION RATE FORPLASMA VOLUME EXPANSION FOLLOWING MAJOR ABDOMINALSURGERY

Phase 1

• Conditions: 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; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2013-004446-42-SE
• Lead Sponsor: Skåne University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-23
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.