Arrhythmias, Microalbuminuria and Corticosteroids

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.

Official Title
-----------------
Arrhythmias, Heart Rate Variability and Microalbuminuria After Intravenous Corticosteroids: An Observational Study

Conditions
-----------------
Corticosteroids Adverse Reaction

Intervention / Treatment
-----------------
* Drug: Corticosteroid injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Starting high-dose intravenous corticotherapy Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Corticosteroid injection|Intravenous high dose corticosteroids|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corticosteroids, Arrhythmia, Heart Rate Variability, Albuminuria