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Completed

NCT Number: 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

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).

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Key information

Conditions

Microvascular Reactivity Tissue Oxygen Saturation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Geloplasma

Drug

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.

Primary outcomes

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

    Time frame: after 3 minutes of postocclusive ischaemia

    Values are measured, using near-infrared spectroscopy.

Secondary outcomes

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

    Time frame: Continuously during cardiopulmonary bypass (= maximum 3 hours).

  2. Change of value of StO2 during cardiopulmonary bypass.

    Time frame: Continuously during cardiopulmonary bypass(= maximum 3 hours).

  3. Change of blood gas analyses during cardiopulmonary bypass.

    Time frame: Continuously during cardiopulmonary bypass(= maximum 3 hours).

  4. Change of haemodynamics during cardiopulmonary bypass.

    Time frame: Continuously during cardiopulmonary bypass(= maximum 3 hours).

  5. Urinary output during cardiopulmonary bypass.

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

  6. Use of vasoactive medication during cardiopulmonary bypass.

    Time frame: During complete cardiopulmonary bypass(= maximum 3 hours).

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 13, 2014
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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