Administration of Warm Blood Cardioplegia With or Without Roller Pump

Coronary Disease Clinical Trial

Official title:

Administration of Warm Blood Cardioplegia With or Without Roller Pump; a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248415
• Other study ID #: NL40355
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: September 25, 2014
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin T high sensitive (TnT-hs) (ng/L)		Change from baseline to the first postoperative day	No
Primary	Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)		Change from baseline to the first postoperative day	No
Primary	N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)		Change from baseline to the first postoperative day	No
Primary	C-reactive protein (CRP) (µg/mL)		Change from baseline to the first postoperative day	No
Secondary	Blood cardioplegia flow during blood cardioplegia delivery (mL/min)		Intraoperative	No
Secondary	Arterial line pressure during blood cardioplegia delivery (mmHg)		Intraoperative	No
Secondary	Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)		Intraoperative	No
Secondary	Aortic root pressure during blood cardioplegia delivery (mmHg)		Intraoperative	No
Secondary	Post-operative myocardial infarction		30-days	No
Secondary	Inotropic support (hours)		30-days	No
Secondary	TIA/CVA		30-days	No
Secondary	Pneumonia		30-days	No
Secondary	Renal failure	Creatine>177 µmol/l/l	30-days	No
Secondary	Re-thoracotomy		30-days	No
Secondary	Atrial fibrillation		30-days	No
Secondary	Length of ICU stay (hours)		30-days	No
Secondary	Length of hospital stay (days)		30-days	No