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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid injection | Drug | Intravenous high dose corticosteroids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmias | All types of arrhythmias (especially pauses and atrial fibrillation). Evaluated with a 72-hours Holter ECG monitoring | Change between day 1 and day 3 |
| Microalbuminuria | Microalbuminuria (mg/dL) | Change in microalbuminuria (day 1 and day 3) |
| Microalbuminuria - Urinary Creatinine ratio | mg/g creatinine | Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Baroreflex Sensitivity | Measured with a Finometer (ms/mmHg) | Change in Baroreflex Sensitivity (day 1 and day 3) |
| Beat-to-beat blood pressure | Measured with a Finometer (mmHg) |
| Measure | Description | Time Frame |
|---|---|---|
| CRP | (mg/L) | before and 1 to 3 days after the drug infusion |
| Glomerular Filtration Rate | CKD-EPI (mL/min/1.73m2) | Before and 1 to 3 days after the drug infusion |
Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients who are starting high-dose corticotherapy in Hôpital Erasme (Brussels).
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| Name | Affiliation | Role |
|---|---|---|
| Marc Leeman, PhD | Université Libre de Bruxelles | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme hospital | Brussels | 1070 | Belgium |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
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| Change in beat-to-beat blood pressure (day 1 and day 3) |
| Heart Rate | Measured with a 72 hours Holter ECG monitoring (bpm) | Change in Heart Rate (day 1 and day 3) |
| Standard Deviation of normal to normal R-R intervals (SDNN) | Measured with a 72 hours Holter ECG monitoring (ms) | Change in SDNN (day 1 and day 3) |
| Root Mean Square of the Successive Differences (RMSSD) | Measured with a 72 hours Holter ECG monitoring (ms) | Change in RMSSD (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) | Measured with a 72 hours Holter ECG monitoring (%) | Change in PNN50 (day 1 and day 3) |
| Low Frequency component of Heart Rate Variability (LF) | Measured with a 72 hours Holter ECG monitoring (ms^2) | Change in low frequencies (day 1 and day 3) |
| High Frequency component of Heart Rate Variability (HF) | Measured with a 72 hours Holter ECG monitoring (ms^2) | Change in high frequencies (day 1 and day 3) |
| Low to High Frequency Ratio of Heart Rate Variability (LF/HF) | Measured with a 72 hours Holter ECG monitoring | Change in LF/HF (day 1 and day 3) |
| Natremia | mmol/L | Change in Natremia (day 1 and day 3) |
| Kaliemia | mmol/L | Change in Kaliemia (day 1 and day 3) |
| Chloremia | mmol/L | Change in Chloremia (day 1 and day 3) |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |