Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

Sahlgrenska University Hospital

Status and phase: Completed; Phase 2

Conditions: Heart Disease

Treatments: Device: A colloid Dextran 40 solution for extracorporeal circulation; Device: Ringer-Acetate and Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT02767154

1003-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

PrimECC

Active Comparator group

Description:

1250 ml of a priming solution based on the colloid Dextran 40 to use for extracorporeal circulation.

Treatment:

Device: A colloid Dextran 40 solution for extracorporeal circulation

Ringer-Acetate/Mannitol

Active Comparator group

Description:

1250 ml of a priming solution based on the crystalloid Ringer-Acetate (1000ml) and Mannitol (250ml).

Treatment:

Device: Ringer-Acetate and Mannitol