Arrhythmias, Heart Rate Variability and Microalbuminuria After Intravenous Corticosteroids: An Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Arrhythmias
Study Overview
Brief Summary
The goal of this observational design is to study the effects of intravenous corticosteroids on heart rate variability, arrhythmias and microalbuminuria. Some previous studies have shown that intravenous corticosteroids could induce bradycardia but also supra-ventricular tachycardia and atrial fibrillation.
A second goal of this study is to investigate whether exogenous corticosteroids may induce microalbuminuria. A large retrospective study has revealed an association between microalbuminuria and corticosteroid use in the year preceding the measurement.
Detailed Description
On intra-hospital patients, it will be explored the prevalence of arrythmias, the heart rate variability and the modification of the microalbuminuria level after intravenous infusion of corticosteroids. The investigator shall not initiate the treatment. Patients will receive high-dose intravenous corticosteroids for the treatment of different diseases. The departments, where the patients are enrolled, are: nephrology, neurology, dermatology and rheumatology and the day hospital. The day before the corticosteroids administration, a holter monitor will be started for at least 24h to detect arrhythmias and heart rate variations. By mean of a Finometer, beat-to-beat blood pressure, cardiac output and baroreflex sensitivity will be measured before, during and after the infusion. Blood and urine samples will be used to explore the effects of corticosteroids on microalbuminuria, electrolytes, CRP and glomerular filtration rate during the 3 days of observation.
To our knowledge, it will be the first prospective trial to explore a link between intravenous corticosteroids administration and heart rate variability, Baroreflex Sensitivity, as well as microalbuminuria.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Starting high-dose intravenous corticotherapy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Arrhythmias
Time Frame: Change between day 1 and day 3
All types of arrhythmias (especially pauses and atrial fibrillation). Evaluated with a 72-hours Holter ECG monitoring
Microalbuminuria - Urinary Creatinine ratio
Time Frame: Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3)
mg/g creatinine
Microalbuminuria
Time Frame: Change in microalbuminuria (day 1 and day 3)
Microalbuminuria (mg/dL)
Secondary Outcomes
- Beat-to-beat blood pressure(Change in beat-to-beat blood pressure (day 1 and day 3))
- Heart Rate(Change in Heart Rate (day 1 and day 3))
- Low Frequency component of Heart Rate Variability (LF)(Change in low frequencies (day 1 and day 3))
- Standard Deviation of normal to normal R-R intervals (SDNN)(Change in SDNN (day 1 and day 3))
- Baroreflex Sensitivity(Change in Baroreflex Sensitivity (day 1 and day 3))
- Root Mean Square of the Successive Differences (RMSSD)(Change in RMSSD (day 1 and day 3))
- High Frequency component of Heart Rate Variability (HF)(Change in high frequencies (day 1 and day 3))
- Mean number of times per hour in which the change in consecutive normal sinus R-R intervals exceeds 50 milliseconds (PNN50)(Change in PNN50 (day 1 and day 3))
- Low to High Frequency Ratio of Heart Rate Variability (LF/HF)(Change in LF/HF (day 1 and day 3))
Investigators
Elza Abdessater
Medical Student (Master 4)
Université Libre de Bruxelles