Arrhythmias, Microalbuminuria and Corticosteroids

NCT03453931 | Completed DMC

• 1 other identifier: P2017/556 / B406201734265
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Corticosteroids Adverse Reaction

Keywords

Corticosteroids; Arrhythmia; Heart Rate Variability; Albuminuria

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Baroreflex Sensitivity

  Change in Baroreflex Sensitivity (day 1 and day 3)

• Beat-to-beat blood pressure

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

• Heart Rate

  Change in Heart Rate (day 1 and day 3)

• Standard Deviation of normal to normal R-R intervals (SDNN)

  Change in SDNN (day 1 and day 3)

• Root Mean Square of the Successive Differences (RMSSD)

  Change in RMSSD (day 1 and day 3)

Other Outcomes (5)

• CRP

  before and 1 to 3 days after the drug infusion

• Glomerular Filtration Rate

  Before and 1 to 3 days after the drug infusion

• Natremia

  Change in Natremia (day 1 and day 3)

Interventions

Corticosteroid injection DRUG

Intravenous high dose corticosteroids

Also known as: Solumedrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Starting high-dose intravenous corticotherapy

You may not qualify if:

• None

Sponsors & Collaborators

• Elza Abdessater: lead

Study Sites (1)

Erasme hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Albuminuria

Interventions

Adrenal Cortex Hormones; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Marc Leeman, PhD

  Université Libre de Bruxelles

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Student (Master 4)

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: March 5, 2018
• Study Start: January 10, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

BE (1)