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

Civil Hospices of Lyon

Status and phase

Completed

Phase 3

Conditions

Cardiac Surgery

Extracorporeal Circulation

Treatments

Drug: Sodium Chloride 0.9% (Fresenius)

Drug: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)

Study type

Interventional

Funder types

Other

Identifiers

NCT02906514

69HCL15_0235

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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