Cardiac Surgery, Extracorporeal Circulation
Conditions
Keywords
Hydroxyethyl Starch, Cardiac surgery, Priming of cardiopulmonary bypass
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.
Interventions
DRUGNon balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)
1000mL used for cardiopulmonary bypass priming
DRUGSodium Chloride 0.9% (Fresenius)
1000mL used for cardiopulmonary bypass priming
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Fluid balance | Hour 0 | 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 24 | — |
| Acid-Base parameters : arterial pH | Hour 24 | — |
| Acid-Base parameters : Base Excess | Hour 0 | — |
| Acid-Base parameters : Lactatemia | Hour 0 | — |
| Acid-Base parameters : Chloremia | Hour 0 | — |
| Coagulation parameters : platelets | Hour 0 | — |
| Coagulation parameters : prothrombin | Hour 0 | — |
| Coagulation parameters : activated partial thromboplastin | Hour 0 | — |
| Coagulation parameters : fibrinogen level | Hour 0 | — |
| Hemoglobin level | Hour 0 | — |
| 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. |
| Revision surgery for bleeding | Hour 12 | — |
| Delay for ablation of surgical drainage | Day of ablation of surgical drainage, 24 hours | — |
| Antiemetic medication use | end of intensive care unit stay, 24 hours | Any antiemetic medication used during this period |
| Delay to first extubation (number of hours) | Hour of first extubation, an average of 5 hours | — |
| Intensive care unit stay (number oh days) | Day of intensive care unit stay exit | — |
| Hospital stay (number of days) | Day of hospital exit, an average of 7 days | — |
| Creatinine level variation | Day 5 | — |
| Renal replacement therapy use during intensive care stay | end of intensive care unit stay, an average of 24 hours | — |
| Renal replacement therapy dependency | Day 28 | — |
| Mortality of any cause | During hospital stay, an average of 7 days | — |
| Surgical bleeding | Hour 12 | — |
Countries
France
Outcome results
None listed