The Importance of Albumin Infusion Rate for Plasma Volume Expansion Following Major Abdominal Surgery

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To study if plasma volume expansion is influenced by the rate at which a colloidal solution is administered in patients with a systemic inflammatory response induced by major abdominal surgery.

Randomization will be performed postoperatively at the day of surgery with a 1:1 ratio with no stratification and the study drug will be given as a slow (3 hours) or rapid (30 minutes) intravenous infusion.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Skane

Criteria

Inclusion Criteria:

1. The patient is scheduled for non-emergent Whipple operation or major gynaecological cancer surgery.

2. Indication for fluid therapy as judged by the anaesthesiologist in charge and at least one at least one of the following criteria is fulfilled:

• Positive "leg raising test" (pulse pressure increase > 9% or stroke volume increase by more than 10% as measured with cardiac ultrasound.

• Central venous oxygen saturation (ScvO2) < 70%.

• Plasma lactate > 2.0 mmol/l.

• Urine output < 0.5 ml / kg for the latest hour.

• Respiratory variation of the inferior vena cava of more than 15% as measured by ultrasound.

• Systolic pressure < 100 mmHg, mean arterial pressure < 55 mmHg

3. Age 40 and above

4. Written consent by patient to participate in the study

Exclusion Criteria:

1. Hypersensitivity to the active drug/ the tracer.

2. Signs of postoperative bleeding.

3. History of heart failure.

4. 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 those included in the protocol.

5. Pregnancy

6. Clinical judgment by the investigator or the treating physician that the patient should not participate in of the study for reasons other than described above.