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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

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ClinicalTrials.gov Identifier: NCT02034682
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE December 11, 2013
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • Change of values of ScO2 during cardiopulmonary bypass (CPB ). [ Time Frame: Continuously during cardiopulmonary bypass (= maximum 3 hours). ]
  • Change of value of StO2 during cardiopulmonary bypass. [ Time Frame: Continuously during cardiopulmonary bypass(= maximum 3 hours). ]
  • Change of blood gas analyses during cardiopulmonary bypass. [ Time Frame: Continuously during cardiopulmonary bypass(= maximum 3 hours). ]
  • Change of haemodynamics during cardiopulmonary bypass. [ Time Frame: Continuously during cardiopulmonary bypass(= maximum 3 hours). ]
  • Urinary output during cardiopulmonary bypass. [ Time Frame: At the end of cardiopulmonary bypass(= after maximum 3 hours).. ]
  • Use of vasoactive medication during cardiopulmonary bypass. [ Time Frame: During complete cardiopulmonary bypass(= maximum 3 hours). ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Microvascular Reactivity
  • Tissue Oxygen Saturation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Volulyte 6%
  • 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
    Intervention: Drug: Geloplasma
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034682
Other Study ID Numbers  ICMJE 2013/1085
2013-005209-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Annelies Moerman, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP