Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.

The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic effect.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

Inclusion Criteria:

• Patients scheduled for elective conventional cardiac surgery with cardiopulmonary bypass

• Patients insured under the French social security system

Exclusion Criteria:

• Pregnancy

• Patients placed under guardianship

• Urgent surgery

• Cardiac surgery without cardiopulmonary bypass

• Anterior cardiac surgery

• Non conventional cardiac surgery (mini-invasive surgery, dual valve replacement, right heart surgery)

• Simultaneous inclusion in another study with potential interference in outcomes

• Heparin-induced thrombocytopenia

• Chronic renal insufficiency (glomerular filtration rate < 60mL.min-1.m-2)

• Nature/nurture hemostasis disorders, in particular Von Willebrand disease and hemophilia

• Hydroxyethyl Starch allergy

• Weight under 33 kg

• Mechanical hemodynamic support at the end of the surgery