Coronary DiseaseNCT02248415
Administration of Warm Blood Cardioplegia With or Without Roller Pump
A study testing No pump, Pump and Blood sample collection: after induction of anaesthesia (T0) in people with Coronary Disease, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
The aim of this study is to compare the effect of warm blood cardioplegia administration with and without roller pump on perioperative myocardial injury, reflected by postoperative biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a minimal extracorporeal circuit (MECC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease
- What is being tested?
- No pump, Pump and Blood sample collection: after induction of anaesthesia (T0)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Mar 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective coronary artery bypass grafting
- Scheduled surgery with less than 3 distal anastomoses
Who cannot join
- Previous cardiac surgery
- Left ventricular ejection fraction <45%
- Chronic renal failure (defined by preoperative creatinine >177 µmol/L)
- Aortic insufficiency ≥ grade 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Warm Blood Cardioplegia With or Without Roller Pump; a Randomized Controlled Trial.
The aim of this study is to compare the effect of warm blood cardioplegia administration with and without roller pump on perioperative myocardial injury, reflected by postoperative biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a minimal extracorporeal circuit (MECC).
Read the detailed description
Patients Sixty-eight patients undergoing elective coronary bypass surgery with a MECC system were consecutively enrolled and randomized into a no pump group (blood cardioplegia administration without roller pump) or pump group (blood cardioplegia administration with roller pump). Exclusion criteria were: previous cardiac surgery, scheduled surgery with less than 3 distal anastomoses, left ventricular ejection fraction <45%, chronic renal failure (defined by preoperative creatinine >177 µmol/L) and aortic insufficiency ≥ grade 1. The medical ethics committee of the St. Antonius Hospital approved this study and written informed consent was obtained for each patient prior to the surgical procedure.
Administration of blood cardioplegia In all patients warm blood cardioplegia was administered via the aortic root immediately after aortic cross-clamping. Warm blood cardioplegia consisted of oxygenated blood with added Potassium Chloride/Magnesium Sulphate (KCl/Mg SO4; Pharmacy Catharina Hospital, Eindhoven, The Netherlands: K+ 1.7 mmol/mL, Cl- 1.7 mmol/mL, Mg2+ 0.17 mmol/mL en SO4- 0.17 mmol/mL). An infusion pump was used for the addition of KCl/Mg SO4. Dosage was based on a blood cardioplegia flow of 200 mL/min and adjusted according to the following protocol: the initial dose of KCl/MgSO4 was 5.7 mmol/min (= 6.7 mL), the second dose was 3.4 mmol/min (= 4 mL) and subsequent doses were 2.6 mmol/min (= 3 mL). Each dose was given over a period of 2 minutes. Every 15 minutes the administration of blood cardioplegia was repeated. In case of recurring ECG activity, blood cardioplegia was given with aberrant intervals.
In the no pump group blood cardioplegia was delivered using the arterial line pressure, created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood cardioplegia flow depended on the difference between arterial line pressure and aortic root pressure. In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.
Blood sample collection and analyses Blood was collected in EDTA tubes (6 mL) at baseline after induction of anaesthesia (T0), after arrival at the ICU (T1), 4 hours in ICU (T2) and at the first postoperative day (T3). Blood samples were fractionated by centrifuging 1500-2000 x g for 15 min. Plasma was collected and stored at -80°C until analysis. The following biomarkers were analysed: Troponin T high sensitive (TnT-hs), Heart-type Fatty Acid Binding Protein (H-FABP), N-terminal brain natriuretic peptide (NT-pro-BNP) and C-reactive protein (CRP).
- Conditions
- Coronary Disease
- Being tested
- No pump, Pump, Blood sample collection: after induction of anaesthesia (T0), Blood sample collection: after arrival at the ICU (T1), Blood sample collection: 4 hours in ICU (T2)
- Keywords
- Cardioplegic Solutions, Myocardial Ischemia
- Medical subject headings
- Coronary Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No pumpOther
In the no pump group blood cardioplegia was delivered using the arterial line pressure, created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood cardioplegia flow depended on the difference between arterial line pressure and aortic root pressure.
PumpOther
In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.
Blood sample collection: after induction of anaesthesia (T0)Other
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: after arrival at the ICU (T1)Other
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: 4 hours in ICU (T2)Other
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: the first postoperative day (T3)Other
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
| Study group | Role | What they receive |
|---|---|---|
| No pump group | Experimental | Blood cardioplegia administration without roller pump Receives: Other: No pump; Other: Blood sample collection: after induction of anaesthesia (T0); Other: Blood sample collection: after arrival at the ICU (T1); Other: Blood sample collection: 4 hours in ICU (T2); Other: Blood sample collection: the first postoperative day (T3) |
| Pump group | Other | Blood cardioplegia administration with roller pump Receives: Other: Pump; Other: Blood sample collection: after induction of anaesthesia (T0); Other: Blood sample collection: after arrival at the ICU (T1); Other: Blood sample collection: 4 hours in ICU (T2); Other: Blood sample collection: the first postoperative day (T3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin T high sensitive (TnT-hs) (ng/L)
Measured: Change from baseline to the first postoperative day
Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)
Measured: Change from baseline to the first postoperative day
N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)
Measured: Change from baseline to the first postoperative day
C-reactive protein (CRP) (μg/mL)
Measured: Change from baseline to the first postoperative day
Secondary outcomes (13)
Blood cardioplegia flow during blood cardioplegia delivery (mL/min)
Measured: Intraoperative
Arterial line pressure during blood cardioplegia delivery (mmHg)
Measured: Intraoperative
Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)
Measured: Intraoperative
Aortic root pressure during blood cardioplegia delivery (mmHg)
Measured: Intraoperative
Post-operative myocardial infarction
Measured: 30-days
Inotropic support (hours)
Measured: 30-days
TIA/CVA
Measured: 30-days
Pneumonia
Measured: 30-days
Renal failure
Creatine>177 μmol/l/l
Measured: 30-days
Re-thoracotomy
Measured: 30-days
Atrial fibrillation
Measured: 30-days
Length of ICU stay (hours)
Measured: 30-days
Length of hospital stay (days)
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mizja M. Faber, St. Antonius Hospital
- Investigators
- Mizja Faber, Faber, Principal investigator, mizjafaber@heartbeat5.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248415
- Sponsor's protocol ID
- NL40355
- Status last verified
- Sep 2014
- First submitted
- 25 Aug 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Warm Blood Cardioplegia With or Without Roller Pump; a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02248415
- Acronym / sponsor ID
- NL40355
- Conditions
- Coronary Disease
- Keywords
- Cardioplegic Solutions, Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Sep 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 the effect of warm blood cardioplegia administration with and without roller pump on perioperative myocardial injury, reflected by postoperative biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a minimal extracorporeal circuit (MECC).
Detailed description
Patients Sixty-eight patients undergoing elective coronary bypass surgery with a MECC system were consecutively enrolled and randomized into a no pump group (blood cardioplegia administration without roller pump) or pump group (blood cardioplegia administration with roller pump). Exclusion criteria were: previous cardiac surgery, scheduled surgery with less than 3 distal anastomoses, left ventricular ejection fraction <45%, chronic renal failure (defined by preoperative creatinine >177 µmol/L) and aortic insufficiency ≥ grade 1. The medical ethics committee of the St. Antonius Hospital approved this study and written informed consent was obtained for each patient prior to the surgical procedure.
Administration of blood cardioplegia In all patients warm blood cardioplegia was administered via the aortic root immediately after aortic cross-clamping. Warm blood cardioplegia consisted of oxygenated blood with added Potassium Chloride/Magnesium Sulphate (KCl/Mg SO4; Pharmacy Catharina Hospital, Eindhoven, The Netherlands: K+ 1.7 mmol/mL, Cl- 1.7 mmol/mL, Mg2+ 0.17 mmol/mL en SO4- 0.17 mmol/mL). An infusion pump was used for the addition of KCl/Mg SO4. Dosage was based on a blood cardioplegia flow of 200 mL/min and adjusted according to the following protocol: the initial dose of KCl/MgSO4 was 5.7 mmol/min (= 6.7 mL), the second dose was 3.4 mmol/min (= 4 mL) and subsequent doses were 2.6 mmol/min (= 3 mL). Each dose was given over a period of 2 minutes. Every 15 minutes the administration of blood cardioplegia was repeated. In case of recurring ECG activity, blood cardioplegia was given with aberrant intervals.
In the no pump group blood cardioplegia was delivered using the arterial line pressure, created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood cardioplegia flow depended on the difference between arterial line pressure and aortic root pressure. In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.
Blood sample collection and analyses Blood was collected in EDTA tubes (6 mL) at baseline after induction of anaesthesia (T0), after arrival at the ICU (T1), 4 hours in ICU (T2) and at the first postoperative day (T3). Blood samples were fractionated by centrifuging 1500-2000 x g for 15 min. Plasma was collected and stored at -80°C until analysis. The following biomarkers were analysed: Troponin T high sensitive (TnT-hs), Heart-type Fatty Acid Binding Protein (H-FABP), N-terminal brain natriuretic peptide (NT-pro-BNP) and C-reactive protein (CRP).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No pump group | Experimental | Other: No pump, Other: Blood sample collection: after induction of anaesthesia (T0), Other: Blood sample collection: after arrival at the ICU (T1), Other: Blood sample collection: 4 hours in ICU (T2), Other: Blood sample collection: the first postoperative day (T3)Blood cardioplegia administration without roller pump |
| Pump group | Other | Other: Pump, Other: Blood sample collection: after induction of anaesthesia (T0), Other: Blood sample collection: after arrival at the ICU (T1), Other: Blood sample collection: 4 hours in ICU (T2), Other: Blood sample collection: the first postoperative day (T3)Blood cardioplegia administration with roller pump |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective coronary artery bypass grafting
- Scheduled surgery with less than 3 distal anastomoses
Key exclusion criteria (4 listed)
- Previous cardiac surgery
- Left ventricular ejection fraction <45%
- Chronic renal failure (defined by preoperative creatinine >177 µmol/L)
- Aortic insufficiency ≥ grade 1
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 |
|---|---|---|
| No pumpIn the no pump group blood cardioplegia was delivered using the arterial line pressure, created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood cardioplegia flow depended on the difference between arterial line pressure and aortic root pressure. | Other | No pump group |
| PumpIn the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min. | Other | Pump group |
| Blood sample collection: after induction of anaesthesia (T0)The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP. | Other | No pump group, Pump group |
| Blood sample collection: after arrival at the ICU (T1)The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP. | Other | No pump group, Pump group |
| Blood sample collection: 4 hours in ICU (T2)The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP. | Other | No pump group, Pump group |
| Blood sample collection: the first postoperative day (T3)The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP. | Other | No pump group, Pump group |
Primary outcome
Troponin T high sensitive (TnT-hs) (ng/L)
Time frame: Change from baseline to the first postoperative day
Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)
Time frame: Change from baseline to the first postoperative day
N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)
Time frame: Change from baseline to the first postoperative day
C-reactive protein (CRP) (μg/mL)
Time frame: Change from baseline to the first postoperative day
13 secondary outcomes
Blood cardioplegia flow during blood cardioplegia delivery (mL/min)
Time frame: Intraoperative
Arterial line pressure during blood cardioplegia delivery (mmHg)
Time frame: Intraoperative
Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)
Time frame: Intraoperative
Aortic root pressure during blood cardioplegia delivery (mmHg)
Time frame: Intraoperative
Post-operative myocardial infarction
Time frame: 30-days
Inotropic support (hours)
Time frame: 30-days
TIA/CVA
Time frame: 30-days
Pneumonia
Time frame: 30-days
Renal failure
Time frame: 30-days
Re-thoracotomy
Time frame: 30-days
Atrial fibrillation
Time frame: 30-days
Length of ICU stay (hours)
Time frame: 30-days
Length of hospital stay (days)
Time frame: 30-days
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 26 Sep 2014.
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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.
Mizja Faber, Faber principal investigator
mizjafaber@heartbeat5.nl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No pump, Pump and Blood sample collection: after induction of anaesthesia (T0) in people with Coronary Disease, run by St. Antonius Hospital at 1 site in Netherlands.
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 2 inclusion and 4 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 26 Sep 2014. 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 Netherlands. 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?
Troponin T high sensitive (TnT-hs) (ng/L) (time frame: Change from baseline to the first postoperative day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2014.