NCT02906514CompletedPhase 3
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
Hospices Civils de Lyon1 site in 1 country30 target enrollmentStarted: December 6, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Supplementary volume of fluid administered during cardiopulmonary bypass (ml)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Hydroxyethyl starch 130/0.4
Experimental
Intervention: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) (Drug)
Sodium Chloride 0.9%
Placebo Comparator
Intervention: Sodium Chloride 0.9% (Fresenius) (Drug)
Outcomes
Primary Outcomes
Supplementary volume of fluid administered during cardiopulmonary bypass (ml)
Time Frame: 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 Outcomes
- Coagulation parameters : platelets(H24)
- Fluid balance(Hour 12)
- Sequential Organ Failure Assessment score(Hour 0)
- Acid-Base parameters : Chloremia(Hour 24)
- 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))
- 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)
- Creatinine level variation(Day 90)
- Renal replacement therapy use during intensive care stay(end of intensive care unit stay, an average of 24 hours)
Investigators
Study Sites (1)
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