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The Effect of Hydroxyethylstarch 6% 130/0.4 in a Balanced Electrolyte Solution (Volulyte®) Compared to Gelatine (Geloplasma®) on Microvascular Reactivity and Tissue Oxygen Saturation During Haemodilution Measured With Near-infrared Spectroscopy

NCT02034682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-24

No results posted yet for this study

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).

Conditions

  • Microvascular Reactivity
  • Tissue Oxygen Saturation

Interventions

DRUG

Volulyte 6%

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.

DRUG

Geloplasma

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.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Annelies Moerman, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-08-31
Completion
2015-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034682 on ClinicalTrials.gov