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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Microvascular Reactivity Tissue Oxygen Saturation Drug: Volulyte 6% Drug: Geloplasma Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
Drug Information available for: Gelatin

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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). ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034682


Locations
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Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Annelies Moerman, MD, PhD University Hospital, Ghent
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02034682    
Other Study ID Numbers: 2013/1085
2013-005209-30 ( EudraCT Number )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015