Condition category
Circulatory System
Date applied
24/12/2005
Date assigned
05/01/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Edmundas Sirvinskas

ORCID ID

Contact details

Eiveniu 2
Kaunas
3000
Lithuania
esirvinskas@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Serum electrolyte level changes can influence the incidence of atrial fibrillation

Ethics approval

Approval of Kaunas Region Ethics Committee for Biomedical Research No. 89/2003

Study design

Randomized placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Atrial fibrillation and serum electrolyte balance disorders

Intervention

Magnesium sulfate infusion versus normal saline as placebo infusion

Intervention type

Drug

Phase

Not Specified

Drug names

Magnesium sulphate

Primary outcome measures

The incidence of atrial fibrillation in both groups

Secondary outcome measures

Correlation between serum electrolyte balance and incidence of atrial fibrillation

Overall trial start date

01/01/2004

Overall trial end date

30/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men undergoing elective coronary artery bypass grafting for ischemic heart disease
2. Serum electrolyte leves within normal ranges
3. No diabetes, pulmonary, liver and renal disfunction disease
4. Sinus rhythm before the surgey
5. No atrial fibrillation in the past

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

165 patients

Participant exclusion criteria

1. Excessive bleeding after the surgery
2. The need of electric heart stimulation after the surgery
3. The need of vasoactive agents after the surgery

Recruitment start date

01/01/2004

Recruitment end date

30/05/2005

Locations

Countries of recruitment

Lithuania

Trial participating centre

Eiveniu 2
Kaunas
3000
Lithuania

Sponsor information

Organisation

Kaunas Medical University, Institute for Biomedical Research (Lithuania)

Sponsor details

Eiveniu 2
Kaunas
3000
Lithuania
sirdiskr@kmu.lt

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Support was provided from departmental sources: Department of Anaesthesiology and Intensive Care, Clinic of Cardiac Surgery, Heart Center, Kaunas Medical University, Lithuania

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes