CompletedPhase 3

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

France30 participantsStarted 2016-12-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Supplementary volume of fluid administered during cardiopulmonary bypass (ml)

Timeframe: Day 1 (From initiation to separation of cardiopulmonary bypass)

Trial details

NCT IDNCT02906514

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

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