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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-06

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Extracorporeal Circulation Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydroxyethyl starch 130/0.4

Group Type EXPERIMENTAL

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

Intervention Type DRUG

1000mL used for cardiopulmonary bypass priming

Sodium Chloride 0.9%

Group Type PLACEBO_COMPARATOR

Sodium Chloride 0.9% (Fresenius)

Intervention Type DRUG

1000mL used for cardiopulmonary bypass priming

Interventions

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

1000mL used for cardiopulmonary bypass priming

Intervention Type DRUG

Sodium Chloride 0.9% (Fresenius)

1000mL used for cardiopulmonary bypass priming

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No