NCT03073304CompletedNot Applicable
A Randomized Controlled Study With the Aim to Compare Crystalloid Prime Solution With a Prime Solution Containing Packed Red Blood Cells in Relation to the Patient's Regional Metabolic Needs and Immunological Influence During Isolated Limb Perfusion
Vastra Gotaland Region1 site in 1 country18 target enrollmentStarted: February 24, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Lactate level during and after perfusion.
Study Overview
Brief Summary
The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient scheduled for treatment with isolated hyperthermic perfusion
- •Age over 18 years.
- •Signed informed consent
Exclusion Criteria
- Not provided
Arms & Interventions
Control
Active Comparator
Erythrocyte based prime solution
Intervention: Erythrocyte based prime solution (Drug)
Intervention
Experimental
Crystalloid based prime solution
Intervention: Crystalloid based prime solution (Drug)
Outcomes
Primary Outcomes
Lactate level during and after perfusion.
Time Frame: 1 hour
Lactate level during and after perfusion.
Secondary Outcomes
- Complications(30 days)
- Oxygen extraction during, and after perfusion.(1 hour)
- Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.(1 hour)
- Hematocrit during and after completion of perfusion.(1 hour)
- Immunological effects(30 days)
Investigators
Roger Olofsson Bagge
Associate professor
Sahlgrenska University Hospital, Sweden
Study Sites (1)
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