Microvascular ReactivityNCT02034682
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
A study testing Volulyte 6% and Geloplasma in people with Microvascular Reactivity and Tissue Oxygen Saturation, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microvascular Reactivity, Tissue Oxygen Saturation
- What is being tested?
- Volulyte 6% and Geloplasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (> 32°C) CPB without blood transfusion. Age ≥ 18 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Microvascular Reactivity, Tissue Oxygen Saturation
- Being tested
- Volulyte 6%, Geloplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
GeloplasmaDrug
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 group | Role | What they receive |
|---|---|---|
| Volulyte 6% | Experimental | - 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 Receives: Drug: Volulyte 6% |
| Geloplasma | Active comparator | 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 Receives: Drug: Geloplasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.
Values are measured, using near-infrared spectroscopy.
Measured: after 3 minutes of postocclusive ischaemia
Secondary outcomes (6)
Change of values of ScO2 during cardiopulmonary bypass (CPB ).
Measured: Continuously during cardiopulmonary bypass (= maximum 3 hours).
Change of value of StO2 during cardiopulmonary bypass.
Measured: Continuously during cardiopulmonary bypass(= maximum 3 hours).
Change of blood gas analyses during cardiopulmonary bypass.
Measured: Continuously during cardiopulmonary bypass(= maximum 3 hours).
Change of haemodynamics during cardiopulmonary bypass.
Measured: Continuously during cardiopulmonary bypass(= maximum 3 hours).
Urinary output during cardiopulmonary bypass.
Measured: At the end of cardiopulmonary bypass(= after maximum 3 hours)..
Use of vasoactive medication during cardiopulmonary bypass.
Measured: During complete cardiopulmonary bypass(= maximum 3 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microvascular ReactivityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annelies Moerman, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034682
- Sponsor's protocol ID
- 2013/1085
- Other IDs
- 2013-005209-30
- Status last verified
- Apr 2015
- First submitted
- 11 Dec 2013
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28834795
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02034682
- Acronym / sponsor ID
- 2013/1085
- Conditions
- Microvascular Reactivity, Tissue Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volulyte 6% | Experimental | Drug: 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 |
| Geloplasma | Active comparator | Drug: GeloplasmaIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (> 32°C) CPB without blood transfusion. Age ≥ 18 years.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Volulyte 6% |
| GeloplasmaDuring elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Geloplasma to the cardiopulmonary bypass circuit. | Drug | Geloplasma |
Primary outcome
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.
6 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Derived from this study: PubMed 28834795Vandenbulcke 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelies Moerman, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volulyte 6% and Geloplasma in people with Microvascular Reactivity and Tissue Oxygen Saturation, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia. (time frame: after 3 minutes of postocclusive ischaemia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02034682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.