NCT02248415

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

August 25, 2014

Last Update Submit

September 25, 2014

Conditions

Coronary Disease

Keywords

Cardioplegic SolutionsMyocardial Ischemia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

No pump group

EXPERIMENTAL

Blood cardioplegia administration without roller pump

Other: No pumpOther: 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)

Pump group

OTHER

Blood cardioplegia administration with roller pump

Other: PumpOther: 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)

Interventions

No pumpOTHER

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.

No pump group
PumpOTHER

In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.

Pump group
Blood sample collection: after induction of anaesthesia (T0)OTHER

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

No pump groupPump group
Blood sample collection: after arrival at the ICU (T1)OTHER

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

No pump groupPump group
Blood sample collection: 4 hours in ICU (T2)OTHER

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

No pump groupPump group
Blood sample collection: the first postoperative day (T3)OTHER

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

No pump groupPump group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

MeSH Terms

Conditions

Coronary DiseaseMyocardial Ischemia

Interventions

Intensive Care UnitsTriiodothyronine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Hospital UnitsHealth FacilitiesHealth Care Facilities Workforce and ServicesThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Mizja Faber, Faber

    mizjafaber@heartbeat5.nl

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

August 25, 2014

First Posted

September 25, 2014

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 26, 2014

Record last verified: 2014-09

Locations

NL(1)