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

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).

Study Overview

• Status: Completed
• Conditions: Microvascular Reactivity; Tissue Oxygen Saturation
• Intervention / Treatment: Drug: Volulyte 6%; Drug: Geloplasma

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria are an ejection fraction < 25%, a known allergy to HES, admission of HES or gelatines within the preceding 2 weeks, renal insufficiency (creatinine > 2.0 mg/dl), significant hepatic disease (liver function tests > 3x upper limit of normal), history of cerebrovascular disease, significant carotid artery stenosis (> 60%), perioperative use of corticosteroids, and need for vasopressor or inotropic therapy before surgery. An expected haematocrit on CPB, calculated based on preoperative haematocrit, calculated blood volume and amount of cardioplegia, of < 23% is also considered an exclusion criterium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volulyte 6%; - 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%; 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.
Active Comparator: Geloplasma; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.	Values are measured, using near-infrared spectroscopy.	after 3 minutes of postocclusive ischaemia

Secondary Outcome Measures

Outcome Measure	Time Frame
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)..
Use of vasoactive medication during cardiopulmonary bypass.	During complete cardiopulmonary bypass(= maximum 3 hours).

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Annelies Moerman, MD, PhD, University Hospital, Ghent

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Estimate): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2013/1085; 2013-005209-30 (EudraCT Number)