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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Extracorporeal Circulation, Cardiac Surgery

Intervention / Treatment
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* Drug: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)
* Drug: Sodium Chloride 0.9% (Fresenius)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxyethyl starch 130/0.4<br> | Drug: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)<br>* 1000mL used for cardiopulmonary bypass priming<br>|
| Placebo Comparator: Sodium Chloride 0.9%<br> | Drug: Sodium Chloride 0.9% (Fresenius)<br>* 1000mL used for cardiopulmonary bypass priming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supplementary volume of fluid administered during cardiopulmonary bypass (ml) | Fluid administered during cardiopulmonary bypass for normal functioning, with the exception of blood product, cardioplegia and priming | Day 1 (From initiation to separation of cardiopulmonary bypass) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass | Continuous monitoring of hematocrit during cardiopulmonary bypass. | Day 1 (From initiation to separation of cardiopulmonary bypass) | 
| Fluid balance | Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings) | Hour 0 | 
| Fluid balance | Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings) | Hour 12 | 
| Sequential Organ Failure Assessment score |  | Hour 24 | 
| Sequential Organ Failure Assessment score |  | Hour 0 | 
| Acid-Base parameters : arterial pH |  | Hour 24 | 
| Acid-Base parameters : Base Excess |  | Hour 0 | 
| Acid-Base parameters : Base Excess |  | H24 | 
| Acid-Base parameters : Lactatemia |  | Hour 0 | 
| Acid-Base parameters : Lactatemia |  | Hour 24 | 
| Acid-Base parameters : Chloremia |  | Hour 0 | 
| Acid-Base parameters : Chloremia |  | Hour 24 | 
| Coagulation parameters : platelets |  | Hour 0 | 
| Coagulation parameters : prothrombin |  | Hour 0 | 
| Coagulation parameters : activated partial thromboplastin |  | Hour 0 | 
| Coagulation parameters : fibrinogen level |  | Hour 0 | 
| Coagulation parameters : platelets |  | H24 | 
| Coagulation parameters : prothrombin |  | H24 | 
| Coagulation parameters : activated partial thromboplastin |  | H24 | 
| Coagulation parameters : fibrinogen level |  | H24 | 
| Hemoglobin level |  | Hour 0 | 
| Hemoglobin level |  | Hour 24 | 
| Surgical bleeding |  | Hour 12 | 
| Surgical bleeding |  | during surgical drainage, an average of 24 hours | 
| Revision surgery for bleeding |  | Hour 12 | 
| Delay for ablation of surgical drainage |  | Day of ablation of surgical drainage, 24 hours | 
| Antiemetic medication use | Any antiemetic medication used during this period | end of intensive care unit stay, 24 hours | 
| 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 | 
| Creatinine level variation |  | Day 28 | 
| Creatinine level variation |  | Day 90 | 
| 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 | 
| Renal replacement therapy dependency |  | Day 90 | 
| Mortality of any cause |  | During hospital stay, an average of 7 days | 
| Mortality of any cause |  | Day 28 | 
| Mortality of any cause |  | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydroxyethyl Starch, Cardiac surgery, Priming of cardiopulmonary bypass