NCT02906514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 6, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 6, 2025

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

August 29, 2016

Last Update Submit

August 1, 2025

Conditions

Extracorporeal CirculationCardiac Surgery

Keywords

Hydroxyethyl StarchCardiac surgeryPriming of cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (39)

  • Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass

    Day 1 (From initiation to separation of cardiopulmonary bypass)

  • Fluid balance

    Hour 0

  • Fluid balance

    Hour 12

  • Sequential Organ Failure Assessment score

    Hour 24

  • Sequential Organ Failure Assessment score

    Hour 0

  • +34 more secondary outcomes

Study Arms (2)

Hydroxyethyl starch 130/0.4

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

Sodium Chloride 0.9%

PLACEBO COMPARATOR
Drug: Sodium Chloride 0.9% (Fresenius)

Interventions

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

1000mL used for cardiopulmonary bypass priming

Hydroxyethyl starch 130/0.4
Sodium Chloride 0.9% (Fresenius)DRUG

1000mL used for cardiopulmonary bypass priming

Sodium Chloride 0.9%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective conventional cardiac surgery with cardiopulmonary bypass
  • Patients insured under the French social security system

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, 69500, France

Location

Related Publications (1)

  • Schweizer R, Lameche M, Coelembier C, Portran P, Fornier W, Colombet B, Grinberg D, Pozzi M, Jacquet-Lagreze M, Fellahi JL. Cardiopulmonary Bypass Priming with Hydroxyethyl Starch 6% 130/0.4 or Sodium Chloride 0.9%: A Preliminary Double-Blind Randomized Controlled Study in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Dec;33(12):3534-3535. doi: 10.1053/j.jvca.2019.05.003. Epub 2019 May 10. No abstract available.

    PMID: 31138465RESULT

MeSH Terms

Interventions

HES 130-0.4Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 20, 2016

Study Start

December 6, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 6, 2025

Record last verified: 2018-02

Locations

FR(1)