Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery
- Conditions
- Extracorporeal CirculationCardiac Surgery
- Interventions
- Drug: Sodium Chloride 0.9% (Fresenius)Drug: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)
- Registration Number
- NCT02906514
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Patients scheduled for elective conventional cardiac surgery with cardiopulmonary bypass
- Patients insured under the French social security system
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sodium Chloride 0.9% Sodium Chloride 0.9% (Fresenius) - Hydroxyethyl starch 130/0.4 Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) -
- Primary Outcome Measures
Name Time Method Supplementary volume of fluid administered during cardiopulmonary bypass (ml) Day 1 (From initiation to separation of cardiopulmonary bypass) Fluid administered during cardiopulmonary bypass for normal functioning, with the exception of blood product, cardioplegia and priming
- Secondary Outcome Measures
Name Time Method Fluid balance Hour 12 Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings)
Sequential Organ Failure Assessment score Hour 0 Acid-Base parameters : Chloremia Hour 24 Coagulation parameters : platelets H24 Delay for ablation of surgical drainage Day of ablation of surgical drainage, 24 hours Delay to first extubation (number of hours) Hour of first extubation, an average of 5 hours Hospital stay (number of days) Day of hospital exit, an average of 7 days Mortality of any cause Day 90 Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass Day 1 (From initiation to separation of cardiopulmonary bypass) Continuous monitoring of hematocrit during cardiopulmonary bypass.
Acid-Base parameters : Lactatemia Hour 24 Intensive care unit stay (number oh days) Day of intensive care unit stay exit Renal replacement therapy dependency Day 90 Acid-Base parameters : arterial pH Hour 24 Acid-Base parameters : Base Excess H24 Coagulation parameters : activated partial thromboplastin H24 Coagulation parameters : fibrinogen level H24 Coagulation parameters : prothrombin H24 Hemoglobin level Hour 24 Surgical bleeding during surgical drainage, an average of 24 hours Revision surgery for bleeding Hour 12 Antiemetic medication use end of intensive care unit stay, 24 hours Any antiemetic medication used during this period
Creatinine level variation Day 90 Renal replacement therapy use during intensive care stay end of intensive care unit stay, an average of 24 hours
Trial Locations
- Locations (1)
Hospices Civils de Lyon - Hopital Louis Pradel
🇫🇷Bron, France