Clinical trial NCT02767154: Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
Official title: A Randomized Controlled Trial Comparing Dextran-based Priming (PrimECC), and Standard Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Disease
Keywords: extracorporeal circulation
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions.

Detailed description: This is a prospective, single center, double-blinded, randomized controlled clinical trial. Eighty patients are randomized 1:1 to either cardiopulmonary bypass with the dextran-based solution or standard priming with Ringer-Acetate and Mannitol.

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.

Eligibility criteria: Inclusion Criteria:

* Age 50 - 75 years
* Elective cardiac surgery procedure with expected CBP time above 90 minutes
* Subject provides a legally effective informed consent.

Exclusion Criteria:

* Known previous cardiac surgery
* 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

Primary outcomes:
measure: Change in oncotic pressure in plasma
timeFrame: After 1 hour of cardiopulmonary bypass
Secondary outcomes:
measure: Change in fluid balance
timeFrame: Within 24 hours after cardiopulmonary bypass
measure: Amount of bleeding
timeFrame: Within 24 hours after cardiopulmonary bypass
measure: Amount of transfusions
timeFrame: Within 24 hours after cardiopulmonary bypass
measure: Change in coagulation (1).
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in coagulation (2).
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in platelet function
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in renal function (1)
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in renal function (2)
timeFrame: After 1 hour of cardiopulmonary bypass
measure: Change in liver function (1)
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in liver function (2)
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in pulmonary function
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in ischemic heart injury marker.
timeFrame: Within 24 hours after cardiopulmonary bypass
measure: Change in brain injury marker (1)
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in brain injury marker (2)
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in brain injury marker (3)
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in brain injury marker (4)
timeFrame: Within 2 hours after cardiopulmonary bypass
measure: Change in inflammatory activation
timeFrame: Within 2 hours after cardiopulmonary bypass
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: VGR
Study officials:
References: