Arrhythmias, Microalbuminuria and Corticosteroids

Corticosteroids Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453931
• Other study ID #: P2017/556 / B406201734265
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2023
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Starting high-dose intravenous corticotherapy

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Corticosteroids Adverse Reaction

Intervention

Drug:
• Corticosteroid injection
Intravenous high dose corticosteroids

Locations

Country	Name	City	State
Belgium	Erasme hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Elza Abdessater

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CRP	(mg/L)	before and 1 to 3 days after the drug infusion
Other	Glomerular Filtration Rate	CKD-EPI (mL/min/1.73m2)	Before and 1 to 3 days after the drug infusion
Other	Natremia	mmol/L	Change in Natremia (day 1 and day 3)
Other	Kaliemia	mmol/L	Change in Kaliemia (day 1 and day 3)
Other	Chloremia	mmol/L	Change in Chloremia (day 1 and day 3)
Primary	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
Primary	Microalbuminuria	Microalbuminuria (mg/dL)	Change in microalbuminuria (day 1 and day 3)
Primary	Microalbuminuria - Urinary Creatinine ratio	mg/g creatinine	Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3)
Secondary	Baroreflex Sensitivity	Measured with a Finometer (ms/mmHg)	Change in Baroreflex Sensitivity (day 1 and day 3)
Secondary	Beat-to-beat blood pressure	Measured with a Finometer (mmHg)	Change in beat-to-beat blood pressure (day 1 and day 3)
Secondary	Heart Rate	Measured with a 72 hours Holter ECG monitoring (bpm)	Change in Heart Rate (day 1 and day 3)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)