Administration of Warm Blood Cardioplegia With or Without Roller Pump
NCT ID: NCT02248415
Last Updated: 2014-09-26
Study Results
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Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2012-09-30
2013-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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No pump group
Blood cardioplegia administration without roller pump
No pump
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.
Blood sample collection: after induction of anaesthesia (T0)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: after arrival at the ICU (T1)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: 4 hours in ICU (T2)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: the first postoperative day (T3)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Pump group
Blood cardioplegia administration with roller pump
Pump
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)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: after arrival at the ICU (T1)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: 4 hours in ICU (T2)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: the first postoperative day (T3)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Interventions
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No pump
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.
Pump
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)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: after arrival at the ICU (T1)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: 4 hours in ICU (T2)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Blood sample collection: the first postoperative day (T3)
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Eligibility Criteria
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Inclusion Criteria
* Scheduled surgery with less than 3 distal anastomoses
Exclusion Criteria
* Left ventricular ejection fraction \<45%
* Chronic renal failure (defined by preoperative creatinine \>177 µmol/L)
* Aortic insufficiency ≥ grade 1
ALL
No
Sponsors
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St. Antonius Hospital
OTHER
Responsible Party
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Mizja M. Faber
MSc
Principal Investigators
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Locations
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St. Antonius Hospital
Nieuwegein, , Netherlands
Countries
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Other Identifiers
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NL40355
Identifier Type: -
Identifier Source: org_study_id
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