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