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

Cardiac Surgery Clinical Trial

— OPTIMUS-PRIME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906514
• Other study ID #: 69HCL15_0235
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2016
• Last updated: February 12, 2018
• Start date: December 6, 2016
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Extracorporeal Circulation

Intervention

Drug:
• Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)
1000mL used for cardiopulmonary bypass priming
• Sodium Chloride 0.9% (Fresenius)
1000mL used for cardiopulmonary bypass priming

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hopital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	Sequential Organ Failure Assessment score		Hour 24
Secondary	Sequential Organ Failure Assessment score		Hour 0
Secondary	Acid-Base parameters : arterial pH		Hour 24
Secondary	Acid-Base parameters : Base Excess		Hour 0
Secondary	Acid-Base parameters : Base Excess		H24
Secondary	Acid-Base parameters : Lactatemia		Hour 0
Secondary	Acid-Base parameters : Lactatemia		Hour 24
Secondary	Acid-Base parameters : Chloremia		Hour 0
Secondary	Acid-Base parameters : Chloremia		Hour 24
Secondary	Coagulation parameters : platelets		Hour 0
Secondary	Coagulation parameters : prothrombin		Hour 0
Secondary	Coagulation parameters : activated partial thromboplastin		Hour 0
Secondary	Coagulation parameters : fibrinogen level		Hour 0
Secondary	Coagulation parameters : platelets		H24
Secondary	Coagulation parameters : prothrombin		H24
Secondary	Coagulation parameters : activated partial thromboplastin		H24
Secondary	Coagulation parameters : fibrinogen level		H24
Secondary	Hemoglobin level		Hour 0
Secondary	Hemoglobin level		Hour 24
Secondary	Surgical bleeding		Hour 12
Secondary	Surgical bleeding		during surgical drainage, an average of 24 hours
Secondary	Revision surgery for bleeding		Hour 12
Secondary	Delay for ablation of surgical drainage		Day of ablation of surgical drainage, 24 hours
Secondary	Antiemetic medication use	Any antiemetic medication used during this period	end of intensive care unit stay, 24 hours
Secondary	Delay to first extubation (number of hours)		Hour of first extubation, an average of 5 hours
Secondary	Intensive care unit stay (number oh days)		Day of intensive care unit stay exit
Secondary	Hospital stay (number of days)		Day of hospital exit, an average of 7 days
Secondary	Creatinine level variation		Day 5
Secondary	Creatinine level variation		Day 28
Secondary	Creatinine level variation		Day 90
Secondary	Renal replacement therapy use during intensive care stay		end of intensive care unit stay, an average of 24 hours
Secondary	Renal replacement therapy dependency		Day 28
Secondary	Renal replacement therapy dependency		Day 90
Secondary	Mortality of any cause		During hospital stay, an average of 7 days
Secondary	Mortality of any cause		Day 28
Secondary	Mortality of any cause		Day 90