NCT02906514

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extracorporeal Circulation
• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)	1000mL used for cardiopulmonary bypass priming
DRUG	Sodium Chloride 0.9% (Fresenius)	1000mL used for cardiopulmonary bypass priming

Timeline

• Start date: 2016-12-06
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-09-20
• Last updated: 2025-08-06

Locations

1 site across 1 country: France