Clinical trial NCT02248415: Administration of Warm Blood Cardioplegia With or Without Roller Pump
Official title: Administration of Warm Blood Cardioplegia With or Without Roller Pump; a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: Cardioplegic Solutions
Myocardial Ischemia
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective coronary artery bypass grafting
* Scheduled surgery with less than 3 distal anastomoses

Exclusion Criteria:

* Previous cardiac surgery
* Left ventricular ejection fraction \<45%
* Chronic renal failure (defined by preoperative creatinine \>177 µmol/L)
* Aortic insufficiency ≥ grade 1

Primary outcomes:
measure: Troponin T high sensitive (TnT-hs) (ng/L)
timeFrame: Change from baseline to the first postoperative day
measure: Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)
timeFrame: Change from baseline to the first postoperative day
measure: N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)
timeFrame: Change from baseline to the first postoperative day
measure: C-reactive protein (CRP) (μg/mL)
timeFrame: Change from baseline to the first postoperative day
Secondary outcomes:
measure: Blood cardioplegia flow during blood cardioplegia delivery (mL/min)
timeFrame: Intraoperative
measure: Arterial line pressure during blood cardioplegia delivery (mmHg)
timeFrame: Intraoperative
measure: Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)
timeFrame: Intraoperative
measure: Aortic root pressure during blood cardioplegia delivery (mmHg)
timeFrame: Intraoperative
measure: Post-operative myocardial infarction
timeFrame: 30-days
measure: Inotropic support (hours)
timeFrame: 30-days
measure: TIA/CVA
timeFrame: 30-days
measure: Pneumonia
timeFrame: 30-days
measure: Renal failure
timeFrame: 30-days
measure: Re-thoracotomy
timeFrame: 30-days
measure: Atrial fibrillation
timeFrame: 30-days
measure: Length of ICU stay (hours)
timeFrame: 30-days
measure: Length of hospital stay (days)
timeFrame: 30-days
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: mizjafaber@heartbeat5.nl
name: Mizja Faber, Faber
role: PRINCIPAL_INVESTIGATOR
References: