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Administration of Warm Blood Cardioplegia With or Without Roller Pump

Primary Purpose

Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
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)
Blood sample collection: the first postoperative day (T3)
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Disease focused on measuring Cardioplegic Solutions, Myocardial Ischemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Antonius Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

No pump group

Pump group

Arm Description

Blood cardioplegia administration without roller pump

Blood cardioplegia administration with roller pump

Outcomes

Primary Outcome Measures

Troponin T high sensitive (TnT-hs) (ng/L)
Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)
N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)
C-reactive protein (CRP) (μg/mL)

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2014
Last Updated
September 25, 2014
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02248415
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Cardioplegic Solutions, Myocardial Ischemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No pump group
Arm Type
Experimental
Arm Description
Blood cardioplegia administration without roller pump
Arm Title
Pump group
Arm Type
Other
Arm Description
Blood cardioplegia administration with roller pump
Intervention Type
Other
Intervention Name(s)
No pump
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pump
Intervention Description
In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.
Intervention Type
Other
Intervention Name(s)
Blood sample collection: after induction of anaesthesia (T0)
Intervention Description
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Intervention Type
Other
Intervention Name(s)
Blood sample collection: after arrival at the ICU (T1)
Intervention Description
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Intervention Type
Other
Intervention Name(s)
Blood sample collection: 4 hours in ICU (T2)
Intervention Description
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Intervention Type
Other
Intervention Name(s)
Blood sample collection: the first postoperative day (T3)
Intervention Description
The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
Primary Outcome Measure Information:
Title
Troponin T high sensitive (TnT-hs) (ng/L)
Time Frame
Change from baseline to the first postoperative day
Title
Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)
Time Frame
Change from baseline to the first postoperative day
Title
N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)
Time Frame
Change from baseline to the first postoperative day
Title
C-reactive protein (CRP) (μg/mL)
Time Frame
Change from baseline to the first postoperative day
Secondary Outcome Measure Information:
Title
Blood cardioplegia flow during blood cardioplegia delivery (mL/min)
Time Frame
Intraoperative
Title
Arterial line pressure during blood cardioplegia delivery (mmHg)
Time Frame
Intraoperative
Title
Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)
Time Frame
Intraoperative
Title
Aortic root pressure during blood cardioplegia delivery (mmHg)
Time Frame
Intraoperative
Title
Post-operative myocardial infarction
Time Frame
30-days
Title
Inotropic support (hours)
Time Frame
30-days
Title
TIA/CVA
Time Frame
30-days
Title
Pneumonia
Time Frame
30-days
Title
Renal failure
Description
Creatine>177 μmol/l/l
Time Frame
30-days
Title
Re-thoracotomy
Time Frame
30-days
Title
Atrial fibrillation
Time Frame
30-days
Title
Length of ICU stay (hours)
Time Frame
30-days
Title
Length of hospital stay (days)
Time Frame
30-days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mizja Faber, Faber
Organizational Affiliation
mizjafaber@heartbeat5.nl
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands

12. IPD Sharing Statement

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Administration of Warm Blood Cardioplegia With or Without Roller Pump

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