Clinical trial NCT02034682: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microvascular Reactivity
Tissue Oxygen Saturation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.
timeFrame: after 3 minutes of postocclusive ischaemia
Secondary outcomes:
measure: Change of values of ScO2 during cardiopulmonary bypass (CPB ).
timeFrame: Continuously during cardiopulmonary bypass (= maximum 3 hours).
measure: Change of value of StO2 during cardiopulmonary bypass.
timeFrame: Continuously during cardiopulmonary bypass(= maximum 3 hours).
measure: Change of blood gas analyses during cardiopulmonary bypass.
timeFrame: Continuously during cardiopulmonary bypass(= maximum 3 hours).
measure: Change of haemodynamics during cardiopulmonary bypass.
timeFrame: Continuously during cardiopulmonary bypass(= maximum 3 hours).
measure: Urinary output during cardiopulmonary bypass.
timeFrame: At the end of cardiopulmonary bypass(= after maximum 3 hours)..
measure: Use of vasoactive medication during cardiopulmonary bypass.
timeFrame: During complete cardiopulmonary bypass(= maximum 3 hours).
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Annelies Moerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.