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

Heart Disease Clinical Trial

Official title:
A Randomized Controlled Trial Comparing Dextran-based Priming (PrimECC), and Standard Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02767154
Study type Interventional
Source Sahlgrenska University Hospital, Sweden
Contact
Status Completed
Phase Phase 2
Start date May 2016
Completion date July 13, 2017
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