NCT01348971

Brief Summary

The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Mar 2011

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

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

May 4, 2011

Last Update Submit

September 24, 2013

Conditions

Coronary Artery Disease

Keywords

sodium nitratecoronary artery bypass surgeryischemia-reperfusionmyocardial injury

Outcome Measures

Primary Outcomes (1)

  • Troponin T release over the perioperative 72-hour period.

    72 hours

Secondary Outcomes (10)

  • Troponin T release over the perioperative 24-hour period.

    24 h

  • Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period

    72 hours

  • Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period

    24 hours

  • Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.

    72 hours

  • Aspartate aminotransferase (AST) release over the perioperative 72-hour period.

    72 hours

  • +5 more secondary outcomes

Study Arms (2)

Sodium nitrate

EXPERIMENTAL

Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery

Dietary Supplement: Sodium nitrate

Placebo

PLACEBO COMPARATOR

Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery

Other: Sodium chloride

Interventions

Sodium nitrateDIETARY_SUPPLEMENT

Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery

Sodium nitrate
Sodium chlorideOTHER

Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing coronary artery bypass surgery
  • Over 18 years of age

You may not qualify if:

  • Over 80 years of age
  • Pregnancy
  • Reoperation
  • Intended heart valve or additional surgery
  • Angina or troponin release above 45 nmol/L \< 48 hours before surgery
  • Medication with organic nitrates/nitrites \< 24 hours before surgery
  • Medication with glibenclamide or corticosteroids
  • Significant renal, pulmonary or hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, S-171 76, Sweden

Location

Related Publications (1)

  • Eriksson KE, Eidhagen F, Liska J, Franco-Cereceda A, Lundberg JO, Weitzberg E. Effects of inorganic nitrate on ischaemia-reperfusion injury after coronary artery bypass surgery: a randomised controlled trial. Br J Anaesth. 2021 Oct;127(4):547-555. doi: 10.1016/j.bja.2021.06.046. Epub 2021 Aug 14.

    PMID: 34399982DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

sodium nitrateSodium Chloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Eddie T Weitzberg, MD,PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 6, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

SE(1)