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Postoperative New-onset Atrial Fibrillation in Cardiac Surgery: DECS-PNAF Project

NCT01143129 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-02-24

No results posted yet for this study

Summary

The DExamethasone for Cardiac Surgery - Postoperative New-onset Atrial Fibrillation (DECS-PNAF) project described in this protocol aims to elucidate how corticosteroids protect cardiac surgical patients from Postoperative New-onset Atrial Fibrillation (PNAF). Patients will be randomized to receive either a single high dose of dexamethasone or a placebo. Continuous ECG-monitoring, echocardiography and biochemical and genomic analyses will be used to investigate the mechanisms responsible for the known protective effect of corticosteroids in the development of PNAF.

Conditions

Interventions

DRUG

Dexamethasone

Single dose (1 mg/kg) at start of cardiac surgical procedure

DRUG

Placebo

Placebo solution in a comparable amount to the experimental drug (0.05 mL/kg)

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-11-30
Completion
2012-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143129 on ClinicalTrials.gov