NCT01098409

Brief Summary

The purpose of this study is to determine whether sodium nitrite administration 24 hours prior to or during coronary artery bypass surgery protects the heart better from lack of blood flow which occurs as part of this type of operation. The study will also determine what the mechanisms of this cardioprotection are.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 2, 2010

Status Verified

January 1, 2010

Enrollment Period

1.9 years

First QC Date

March 30, 2010

Last Update Submit

April 1, 2010

Conditions

Coronary Artery Bypass Surgery

Keywords

sodium nitritecoronary artery bypass surgerycardioprotectionmyocardial injury

Outcome Measures

Primary Outcomes (1)

  • Troponin T

    Biochemical marker of myocardial injury

    72 hours post release of aortic cross clamp

Secondary Outcomes (18)

  • Troponin T

    6 hours post release of aortic cross clamp

  • troponin T

    12 hours post release of aortic cross clamp

  • Troponin T

    24 hours post release of aortic cross clamp

  • Troponin T

    48 hours post release of aortic cross clamp

  • Creatinine Kinase myocardial Fraction (CKMB)

    6 hours post release of aortic cross clamp

  • +13 more secondary outcomes

Study Arms (3)

sodium nitrite 24 hours before

EXPERIMENTAL
Drug: sodium nitrite

sodium nitrite during surgery

EXPERIMENTAL
Drug: sodium nitrite

0.9% sodium chloride

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride

Interventions

sodium nitriteDRUG

0.2mcg/kg/min or 1mcg/kg/min intravenous for 30minutes at 1ml/min

sodium nitrite 24 hours beforesodium nitrite during surgery
0.9% sodium chlorideDRUG

intravenous 0.9% sodium chloride over 30minutes at 1ml/min

0.9% sodium chloride

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective first time multi-vessel coronary artery bypass surgery
  • Older than 18 years of age

You may not qualify if:

  • Significant psychiatric /neurological impairment that might prevent adherence to the requirements of the protocol or the ability to give informed consent
  • Inability to read the Information Sheet.
  • Redo operation
  • Age \>80 years
  • Pregnancy
  • Renal Impairment requiring pre-operative renal support
  • Diabetes Mellitus
  • Intended heart valve or additional surgery
  • Episodes of angina or ischemia within 48hours prior to the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham NHS Trust

Birmingham, B15 2TH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Sodium NitriteSodium Chloride

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Michael P Frenneaux, MD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sayqa Arif, MBChB

CONTACT

0044(1)214145916s.arif@bham.ac.uk

Robert Bonser, MD

CONTACT

0044(1)214721311robert.bonser@uhb.nhs.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2010

First Posted

April 2, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2012

Study Completion

July 1, 2012

Last Updated

April 2, 2010

Record last verified: 2010-01

Locations

GB(1)