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Coronary Artery Bypass and Nitrate Oral Supplementation

NCT ID: NCT01348971

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Nitric oxide (NO) is an important mediator in the cardiovascular system and has been shown to have protective properties in ischemia-reperfusion injury. Inorganic nitrate, an oxidation product from endogenous NO production and also a constituent in green leafy vegetables, can be recycled, via nitrite, back to bioactive NO in the body. Recent research has shown beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion injury. Moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in humans.

During coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin T is most often released from the myocardium. The aim of the present study is to investigate if preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin T release as well as other surrogate markers of injury to the liver, kidneys and the brain. In addition, plasma and urine samples will be collected for markers of oxidative stress and inflammation (sCRP and cytokines). Patients planned for bypass surgery who give their written informed consent will, the night before surgery, get a standardized, low-nitrate meal where after they receive sodium nitrate on two occasions preoperatively; the night before and in the morning before surgery. Plasma and urine samples will be collected at various time points up to 72 hours after surgery.

Conditions

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Coronary Artery Disease

Keywords

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sodium nitrate coronary artery bypass surgery ischemia-reperfusion myocardial injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium nitrate

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

Group Type EXPERIMENTAL

Sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type OTHER

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

Interventions

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Sodium nitrate

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

Intervention Type DIETARY_SUPPLEMENT

Sodium chloride

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Eddie Weitzberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eddie T Weitzberg, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34399982 (View on PubMed)

Other Identifiers

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KI-101

Identifier Type: -

Identifier Source: org_study_id