Pancreatic Neoplasms Clinical Trial
— AIROfficial title:
The Importance of Albumin Infusion Rate for Plasma Volume Expansion. AIR. A Phase III Assessor Blinded Parallel Group Randomized Study
Verified date | April 2017 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | November 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Skåne University Hospital, Region Skåne | Lund |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Transcapillary escape rate (TER) for albumin | 180-240 min after start of infusion | ||
Other | Change in heart rate, change in central venous oxygen saturation, change in haemoglobin concentration in blood, change in blood pressure, change in central venous pressure, change in plasma lactate and diuresis. | From start of infusion until 3 hours after start of infusion | ||
Primary | Change in plasma volume | From start of infusion until 3 hours after start of infusion | ||
Secondary | Change in plasma volume over time | Integral of plasma volume over time | From start of infusion until 3 hours after start of infusion | |
Secondary | Incidence of postoperative complications | 30 days postoperatively |
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