MedPath

Arrhythmias, Microalbuminuria and Corticosteroids

Completed
Conditions
Corticosteroids Adverse Reaction
Registration Number
NCT03453931
Lead Sponsor
Elza Abdessater
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Starting high-dose intravenous corticotherapy
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Exclusion Criteria
  • None
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ArrhythmiasChange 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 ratioChange in microalbuminuria - urinary creatinine ratio (day 1 and day 3)

mg/g creatinine

MicroalbuminuriaChange in microalbuminuria (day 1 and day 3)

Microalbuminuria (mg/dL)

Secondary Outcome Measures
NameTimeMethod
Heart RateChange in Heart Rate (day 1 and day 3)

Measured with a 72 hours Holter ECG monitoring (bpm)

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)

Baroreflex SensitivityChange in Baroreflex Sensitivity (day 1 and day 3)

Measured with a Finometer (ms/mmHg)

Beat-to-beat blood pressureChange in beat-to-beat blood pressure (day 1 and day 3)

Measured with a Finometer (mmHg)

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)

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)

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)

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 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

Trial Locations

Locations (1)

Erasme hospital

🇧🇪

Brussels, Belgium

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