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

Tissue Oxygen Saturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034682
• Other study ID #: 2013/1085
• Secondary ID: 2013-005209-30
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: April 23, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Microvascular Reactivity
• Tissue Oxygen Saturation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.	Values are measured, using near-infrared spectroscopy.	after 3 minutes of postocclusive ischaemia	No
Secondary	Change of values of ScO2 during cardiopulmonary bypass (CPB ).		Continuously during cardiopulmonary bypass (= maximum 3 hours).	No
Secondary	Change of value of StO2 during cardiopulmonary bypass.		Continuously during cardiopulmonary bypass(= maximum 3 hours).	No
Secondary	Change of blood gas analyses during cardiopulmonary bypass.		Continuously during cardiopulmonary bypass(= maximum 3 hours).	No
Secondary	Change of haemodynamics during cardiopulmonary bypass.		Continuously during cardiopulmonary bypass(= maximum 3 hours).	No
Secondary	Urinary output during cardiopulmonary bypass.		At the end of cardiopulmonary bypass(= after maximum 3 hours)..	No
Secondary	Use of vasoactive medication during cardiopulmonary bypass.		During complete cardiopulmonary bypass(= maximum 3 hours).	No

External Links

•   Link