Arrhythmias, Microalbuminuria and Corticosteroids

NCT ID: NCT03453931

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2018-06-30

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.

Conditions

Corticosteroids Adverse Reaction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Corticosteroid injection

Intravenous high dose corticosteroids

Intervention Type: DRUG

Other Intervention Names

Solumedrol

Eligibility Criteria

Inclusion Criteria

• Starting high-dose intravenous corticotherapy

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elza Abdessater

OTHER

Sponsor Role: lead

Responsible Party

Elza Abdessater

Medical Student (Master 4)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marc Leeman, PhD

Role: STUDY_DIRECTOR

Université Libre de Bruxelles

Locations

Erasme hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

P2017/556 / B406201734265

Identifier Type: -

Identifier Source: org_study_id