Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
NCT ID: NCT02767154
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2016-05-31
2017-07-13
Brief Summary
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Detailed Description
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Primary endpoint will be oncotic pressure during cardio pulmonary bypass. Secondary endpoints include perioperative fluid balance, coagulation, platelet function, postoperative bleeding volume, transfusion requirements, renal function, liver function, pulmonary function, inflammatory activation and markers for brain and heart injury.
Blood samples for oncotic pressure measurements will be collected from an arterial line before and during surgery. Organ function will be assessed before surgery and 2 hours cardio pulmonary bypass.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PrimECC
1250 ml of a priming solution based on the colloid Dextran 40 to use for extracorporeal circulation.
A colloid Dextran 40 solution for extracorporeal circulation
The oncotic pressure of the PrimECC solution is higher than that of a crystalloid Ringer-acetate/mannitol solution. It should maintain the plasma oncotic pressure during and after cardiopulmonary bypass (CPB). Subsequently, the leakage of fluids from the systemic circulation to the interstitial compartment during CPB can be reduced, and a higher plasma volume and a better fluid balance can be achieved.
Ringer-Acetate/Mannitol
1250 ml of a priming solution based on the crystalloid Ringer-Acetate (1000ml) and Mannitol (250ml).
Ringer-Acetate and Mannitol
Currently clinic standard for priming the CPB circuit.
Interventions
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A colloid Dextran 40 solution for extracorporeal circulation
The oncotic pressure of the PrimECC solution is higher than that of a crystalloid Ringer-acetate/mannitol solution. It should maintain the plasma oncotic pressure during and after cardiopulmonary bypass (CPB). Subsequently, the leakage of fluids from the systemic circulation to the interstitial compartment during CPB can be reduced, and a higher plasma volume and a better fluid balance can be achieved.
Ringer-Acetate and Mannitol
Currently clinic standard for priming the CPB circuit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective cardiac surgery procedure with expected CBP time above 90 minutes
* Subject provides a legally effective informed consent.
Exclusion Criteria
* Coagulation disorder
* Malignancy
* Kidney failure
* Liver failure
* Ongoing septicaemia
* Ongoing antithrombotic treatment other than acetylsalicylic acid
* Systemic inflammatory disorders treated with corticosteroids
* Not able to understand Swedish
50 Years
75 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Anders Jeppssons
MD, PhD, Professor/Senior consultant
Locations
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Sahlgrenska University Hospital
Gothenburg, VGR, Sweden
Countries
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Other Identifiers
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1003-15
Identifier Type: -
Identifier Source: org_study_id