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

Hospices Civils de Lyon30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Extracorporeal Circulation Cardiac Surgery

Interventions

Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)DRUG

1000mL used for cardiopulmonary bypass priming

Sodium Chloride 0.9% (Fresenius)DRUG

1000mL used for cardiopulmonary bypass priming

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, France

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass

Continuous monitoring of hematocrit during cardiopulmonary bypass.

Time frame: 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)

Time frame: 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)

Time frame: Hour 12

Sequential Organ Failure Assessment score

Time frame: Hour 24

Sequential Organ Failure Assessment score

Time frame: Hour 0

Acid-Base parameters : arterial pH

Time frame: Hour 24

Acid-Base parameters : Base Excess

Time frame: Hour 0

Data from ClinicalTrials.gov

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