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Completed

NCT Number: NCT02248415

Administration of Warm Blood Cardioplegia With or Without Roller Pump

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No pump

Other

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

Other

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)

Other

The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.

Blood sample collection: after arrival at the ICU (T1)

Other

The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.

Blood sample collection: 4 hours in ICU (T2)

Other

The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.

Blood sample collection: the first postoperative day (T3)

Other

The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.

Primary outcomes

  1. Troponin T high sensitive (TnT-hs) (ng/L)

    Time frame: Change from baseline to the first postoperative day

  2. Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)

    Time frame: Change from baseline to the first postoperative day

  3. N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)

    Time frame: Change from baseline to the first postoperative day

  4. C-reactive protein (CRP) (μg/mL)

    Time frame: Change from baseline to the first postoperative day

Secondary outcomes

  1. Blood cardioplegia flow during blood cardioplegia delivery (mL/min)

    Time frame: Intraoperative

  2. Arterial line pressure during blood cardioplegia delivery (mmHg)

    Time frame: Intraoperative

  3. Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)

    Time frame: Intraoperative

  4. Aortic root pressure during blood cardioplegia delivery (mmHg)

    Time frame: Intraoperative

  5. Post-operative myocardial infarction

    Time frame: 30-days

  6. Inotropic support (hours)

    Time frame: 30-days

  7. TIA/CVA

    Time frame: 30-days

  8. Pneumonia

    Time frame: 30-days

  9. Renal failure

    Time frame: 30-days

    Creatine>177 μmol/l/l

  10. Re-thoracotomy

    Time frame: 30-days

  11. Atrial fibrillation

    Time frame: 30-days

  12. Length of ICU stay (hours)

    Time frame: 30-days

  13. Length of hospital stay (days)

    Time frame: 30-days

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2014
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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