Clinical trial NCT03453931: Arrhythmias, Microalbuminuria and Corticosteroids
Official title: Arrhythmias, Heart Rate Variability and Microalbuminuria After Intravenous Corticosteroids: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corticosteroids Adverse Reaction
Keywords: Corticosteroids
Arrhythmia
Heart Rate Variability
Albuminuria
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients who are starting high-dose corticotherapy in Hôpital Erasme (Brussels).

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.

Eligibility criteria: Inclusion Criteria:

* Starting high-dose intravenous corticotherapy

Exclusion Criteria:

* None

Primary outcomes:
measure: Arrhythmias
timeFrame: Change between day 1 and day 3
measure: Microalbuminuria
timeFrame: Change in microalbuminuria (day 1 and day 3)
measure: Microalbuminuria - Urinary Creatinine ratio
timeFrame: Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3)
Secondary outcomes:
measure: Baroreflex Sensitivity
timeFrame: Change in Baroreflex Sensitivity (day 1 and day 3)
measure: Beat-to-beat blood pressure
timeFrame: Change in beat-to-beat blood pressure (day 1 and day 3)
measure: Heart Rate
timeFrame: Change in Heart Rate (day 1 and day 3)
measure: Standard Deviation of normal to normal R-R intervals (SDNN)
timeFrame: Change in SDNN (day 1 and day 3)
measure: Root Mean Square of the Successive Differences (RMSSD)
timeFrame: Change in RMSSD (day 1 and day 3)
measure: Mean number of times per hour in which the change in consecutive normal sinus R-R intervals exceeds 50 milliseconds (PNN50)
timeFrame: Change in PNN50 (day 1 and day 3)
measure: Low Frequency component of Heart Rate Variability (LF)
timeFrame: Change in low frequencies (day 1 and day 3)
measure: High Frequency component of Heart Rate Variability (HF)
timeFrame: Change in high frequencies (day 1 and day 3)
measure: Low to High Frequency Ratio of Heart Rate Variability (LF/HF)
timeFrame: Change in LF/HF (day 1 and day 3)
Other outcomes:
measure: CRP
timeFrame: before and 1 to 3 days after the drug infusion
measure: Glomerular Filtration Rate
timeFrame: Before and 1 to 3 days after the drug infusion
measure: Natremia
timeFrame: Change in Natremia (day 1 and day 3)
measure: Kaliemia
timeFrame: Change in Kaliemia (day 1 and day 3)
measure: Chloremia
timeFrame: Change in Chloremia (day 1 and day 3)
Locations:
city: Brussels
country: Belgium
facility: Erasme hospital
Study officials:
affiliation: Université Libre de Bruxelles
name: Marc Leeman, PhD
role: STUDY_DIRECTOR
References: