NCT02034682

Brief Summary

The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using near-infrared spectroscopy (NIRS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

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

December 11, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

December 11, 2013

Last Update Submit

April 23, 2015

Conditions

Microvascular ReactivityTissue Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

  • Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.

    Values are measured, using near-infrared spectroscopy.

    after 3 minutes of postocclusive ischaemia

Secondary Outcomes (6)

  • Change of values of ScO2 during cardiopulmonary bypass (CPB ).

    Continuously during cardiopulmonary bypass (= maximum 3 hours).

  • Change of value of StO2 during cardiopulmonary bypass.

    Continuously during cardiopulmonary bypass(= maximum 3 hours).

  • Change of blood gas analyses during cardiopulmonary bypass.

    Continuously during cardiopulmonary bypass(= maximum 3 hours).

  • Change of haemodynamics during cardiopulmonary bypass.

    Continuously during cardiopulmonary bypass(= maximum 3 hours).

  • Urinary output during cardiopulmonary bypass.

    At the end of cardiopulmonary bypass(= after maximum 3 hours)..

  • +1 more secondary outcomes

Study Arms (2)

Volulyte 6%

EXPERIMENTAL

\- Volulyte 6% (HES 130/0.4 in an isotonic composition). In 1000 ml: * Maize starch 60 gr. Molar substitution 0.38-0.45. 130000 Da * Na acetate trihydrate 4.63 gr * Sodium Chloride 6.02 gr * Potassium Chloride 0.3 gr * MgCl 0.3 gr * Sodium hydroxide-hydrochloric acid \& H2O

Drug: Volulyte 6%

Geloplasma

ACTIVE COMPARATOR

In 1000 ml: * Modified fluid gelatin 30 gr * Sodium Chloride 5.4 gr * Potassium Chloride 0.37 gr * MgCl 0.14 gr * Sodium lactate 3.36 gr

Drug: Geloplasma

Interventions

Volulyte 6%DRUG

During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Volulyte 6% to the cardiopulmonary bypass circuit.

Volulyte 6%
GeloplasmaDRUG

During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Geloplasma to the cardiopulmonary bypass circuit.

Geloplasma

Eligibility Criteria

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

You may qualify if:

  • Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (\> 32°C) CPB without blood transfusion. Age ≥ 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Vandenbulcke L, Lapage KG, Vanderstraeten KV, De Somer FM, De Hert SG, Moerman AT. Microvascular reactivity monitored with near-infrared spectroscopy is impaired after induction of anaesthesia in cardiac surgery patients: An observational study. Eur J Anaesthesiol. 2017 Oct;34(10):688-694. doi: 10.1097/EJA.0000000000000684.

    PMID: 28834795DERIVED

Related Links

Study Officials

  • Annelies Moerman, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

January 13, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

April 1, 2015

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

BE(1)