NCT01143129

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 atrial-fibrillation

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

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

June 11, 2010

Last Update Submit

February 21, 2014

Conditions

Atrial FibrillationCardiac Surgery

Keywords

Atrial fibrillationCardiac surgeryCardiopulmonary bypassNew-onset

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation

    5 days (postoperatively)

Study Arms (2)

dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DexamethasoneDRUG

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

dexamethasone
PlaceboDRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

  • On-pump coronary artery bypass graft (CABG)

You may not qualify if:

  • age \< 18 years
  • preexisting cardiac rhythm disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3543CX, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist in training

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 14, 2010

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

NL(1)