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

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

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 Overview

• Status: Completed
• Conditions: Cardiac Surgery; Extracorporeal Circulation
• Intervention / Treatment: Drug: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius); Drug: Sodium Chloride 0.9% (Fresenius)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon - Hopital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac surgery; Hydroxyethyl Starch; Priming of cardiopulmonary bypass
• Additional Relevant MeSH Terms: Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: 69HCL15_0235