Clinical trial NCT02906514: Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Extracorporeal Circulation
Cardiac Surgery
Keywords: Hydroxyethyl Starch
Cardiac surgery
Priming of cardiopulmonary bypass
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Supplementary volume of fluid administered during cardiopulmonary bypass (ml)
timeFrame: Day 1 (From initiation to separation of cardiopulmonary bypass)
Secondary outcomes:
measure: Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass
timeFrame: Day 1 (From initiation to separation of cardiopulmonary bypass)
measure: Fluid balance
timeFrame: Hour 0
measure: Fluid balance
timeFrame: Hour 12
measure: Sequential Organ Failure Assessment score
timeFrame: Hour 24
measure: Sequential Organ Failure Assessment score
timeFrame: Hour 0
measure: Acid-Base parameters : arterial pH
timeFrame: Hour 24
measure: Acid-Base parameters : Base Excess
timeFrame: Hour 0
measure: Acid-Base parameters : Base Excess
timeFrame: H24
measure: Acid-Base parameters : Lactatemia
timeFrame: Hour 0
measure: Acid-Base parameters : Lactatemia
timeFrame: Hour 24
measure: Acid-Base parameters : Chloremia
timeFrame: Hour 0
measure: Acid-Base parameters : Chloremia
timeFrame: Hour 24
measure: Coagulation parameters : platelets
timeFrame: Hour 0
measure: Coagulation parameters : prothrombin
timeFrame: Hour 0
measure: Coagulation parameters : activated partial thromboplastin
timeFrame: Hour 0
measure: Coagulation parameters : fibrinogen level
timeFrame: Hour 0
measure: Coagulation parameters : platelets
timeFrame: H24
measure: Coagulation parameters : prothrombin
timeFrame: H24
measure: Coagulation parameters : activated partial thromboplastin
timeFrame: H24
measure: Coagulation parameters : fibrinogen level
timeFrame: H24
measure: Hemoglobin level
timeFrame: Hour 0
measure: Hemoglobin level
timeFrame: Hour 24
measure: Surgical bleeding
timeFrame: Hour 12
measure: Surgical bleeding
timeFrame: during surgical drainage, an average of 24 hours
measure: Revision surgery for bleeding
timeFrame: Hour 12
measure: Delay for ablation of surgical drainage
timeFrame: Day of ablation of surgical drainage, 24 hours
measure: Antiemetic medication use
timeFrame: end of intensive care unit stay, 24 hours
measure: Delay to first extubation (number of hours)
timeFrame: Hour of first extubation, an average of 5 hours
measure: Intensive care unit stay (number oh days)
timeFrame: Day of intensive care unit stay exit
measure: Hospital stay (number of days)
timeFrame: Day of hospital exit, an average of 7 days
measure: Creatinine level variation
timeFrame: Day 5
measure: Creatinine level variation
timeFrame: Day 28
measure: Creatinine level variation
timeFrame: Day 90
measure: Renal replacement therapy use during intensive care stay
timeFrame: end of intensive care unit stay, an average of 24 hours
measure: Renal replacement therapy dependency
timeFrame: Day 28
measure: Renal replacement therapy dependency
timeFrame: Day 90
measure: Mortality of any cause
timeFrame: During hospital stay, an average of 7 days
measure: Mortality of any cause
timeFrame: Day 28
measure: Mortality of any cause
timeFrame: Day 90
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hopital Louis Pradel
Study officials:
References: