Administration of Warm Blood Cardioplegia With or Without Roller Pump

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).

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: 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); Other: Pump

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No pump group; Blood cardioplegia administration without roller pump	Other: 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.; Other: Blood sample collection: after induction of anaesthesia (T0); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.; Other: Blood sample collection: after arrival at the ICU (T1); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.; Other: Blood sample collection: 4 hours in ICU (T2); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.; Other: Blood sample collection: the first postoperative day (T3); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Other: Pump group; Blood cardioplegia administration with roller pump	Other: Blood sample collection: after induction of anaesthesia (T0); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.; Other: Blood sample collection: after arrival at the ICU (T1); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.; Other: Blood sample collection: 4 hours in ICU (T2); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.; Other: Blood sample collection: the first postoperative day (T3); The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.; Other: Pump; In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Troponin T high sensitive (TnT-hs) (ng/L)	Change from baseline to the first postoperative day
Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)	Change from baseline to the first postoperative day
N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)	Change from baseline to the first postoperative day
C-reactive protein (CRP) (μg/mL)	Change from baseline to the first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood cardioplegia flow during blood cardioplegia delivery (mL/min)		Intraoperative
Arterial line pressure during blood cardioplegia delivery (mmHg)		Intraoperative
Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)		Intraoperative
Aortic root pressure during blood cardioplegia delivery (mmHg)		Intraoperative
Post-operative myocardial infarction		30-days
Inotropic support (hours)		30-days
TIA/CVA		30-days
Pneumonia		30-days
Renal failure	Creatine>177 μmol/l/l	30-days
Re-thoracotomy		30-days
Atrial fibrillation		30-days
Length of ICU stay (hours)		30-days
Length of hospital stay (days)		30-days

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Investigators: Principal Investigator: Mizja Faber, Faber, mizjafaber@heartbeat5.nl

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: September 20, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Estimate): September 26, 2014
• Last Update Submitted That Met QC Criteria: September 25, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Myocardial Ischemia; Cardioplegic Solutions
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: NL40355