Corticosteroids Adverse Reaction
Conditions
Keywords
Corticosteroids, Arrhythmia, Heart Rate Variability, Albuminuria
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.
Interventions
DRUGCorticosteroid injection
Intravenous high dose corticosteroids
Sponsors
Elza Abdessater
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Starting high-dose intravenous corticotherapy
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmias | 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 | Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3) | mg/g creatinine |
| Microalbuminuria | Change in microalbuminuria (day 1 and day 3) | Microalbuminuria (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baroreflex Sensitivity | Change in Baroreflex Sensitivity (day 1 and day 3) | Measured with a Finometer (ms/mmHg) |
| Root Mean Square of the Successive Differences (RMSSD) | Change in RMSSD (day 1 and day 3) | Measured with a 72 hours Holter ECG monitoring (ms) |
| 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) | Measured with a 72 hours Holter ECG monitoring (%) |
| Low Frequency component of Heart Rate Variability (LF) | Change in low frequencies (day 1 and day 3) | Measured with a 72 hours Holter ECG monitoring (ms\^2) |
| High Frequency component of Heart Rate Variability (HF) | Change in high frequencies (day 1 and day 3) | Measured with a 72 hours Holter ECG monitoring (ms\^2) |
| Low to High Frequency Ratio of Heart Rate Variability (LF/HF) | Change in LF/HF (day 1 and day 3) | Measured with a 72 hours Holter ECG monitoring |
| Standard Deviation of normal to normal R-R intervals (SDNN) | Change in SDNN (day 1 and day 3) | Measured with a 72 hours Holter ECG monitoring (ms) |
| Beat-to-beat blood pressure | Change in beat-to-beat blood pressure (day 1 and day 3) | Measured with a Finometer (mmHg) |
| Heart Rate | Change in Heart Rate (day 1 and day 3) | Measured with a 72 hours Holter ECG monitoring (bpm) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chloremia | Change in Chloremia (day 1 and day 3) | mmol/L |
| Natremia | Change in Natremia (day 1 and day 3) | mmol/L |
| Glomerular Filtration Rate | Before and 1 to 3 days after the drug infusion | CKD-EPI (mL/min/1.73m2) |
| Kaliemia | Change in Kaliemia (day 1 and day 3) | mmol/L |
| CRP | before and 1 to 3 days after the drug infusion | (mg/L) |
Countries
Belgium
Outcome results
None listed