Arrhythmias, Microalbuminuria and Corticosteroids

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

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.

Study Overview

• Status: Completed
• Conditions: Corticosteroids Adverse Reaction
• Intervention / Treatment: Drug: Corticosteroid injection

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients who are starting high-dose corticotherapy in Hôpital Erasme (Brussels).

Description

Inclusion Criteria:

• Starting high-dose intravenous corticotherapy

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

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)

Other Outcome Measures

Outcome Measure	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
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)

Collaborators and Investigators

• Sponsor: Elza Abdessater
• Investigators: Study Director: Marc Leeman, PhD, Université Libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Arrhythmia; Heart Rate Variability; Albuminuria; Corticosteroids
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Methylprednisolone Hemisuccinate
• Other Study ID Numbers: P2017/556 / B406201734265

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No