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Completed

NCT Number: NCT03453931

Arrhythmias, Microalbuminuria and Corticosteroids

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.

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Key information

Conditions

Corticosteroids Adverse Reaction Albuminuria Arrhythmias, Cardiac Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme hospital

Brussels, 1070, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Starting high-dose intravenous corticotherapy

Exclusion criteria

  • None

Treatment and study plan

Corticosteroid injection

Drug

Intravenous high dose corticosteroids

Other names: Solumedrol

Primary outcomes

  1. Arrhythmias

    Time frame: Change between day 1 and day 3

    All types of arrhythmias (especially pauses and atrial fibrillation). Evaluated with a 72-hours Holter ECG monitoring

  2. Microalbuminuria

    Time frame: Change in microalbuminuria (day 1 and day 3)

    Microalbuminuria (mg/dL)

  3. Microalbuminuria - Urinary Creatinine ratio

    Time frame: Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3)

    mg/g creatinine

Secondary outcomes

  1. Baroreflex Sensitivity

    Time frame: Change in Baroreflex Sensitivity (day 1 and day 3)

    Measured with a Finometer (ms/mmHg)

  2. Beat-to-beat blood pressure

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

    Measured with a Finometer (mmHg)

  3. Heart Rate

    Time frame: Change in Heart Rate (day 1 and day 3)

    Measured with a 72 hours Holter ECG monitoring (bpm)

  4. Standard Deviation of normal to normal R-R intervals (SDNN)

    Time frame: Change in SDNN (day 1 and day 3)

    Measured with a 72 hours Holter ECG monitoring (ms)

  5. Root Mean Square of the Successive Differences (RMSSD)

    Time frame: Change in RMSSD (day 1 and day 3)

    Measured with a 72 hours Holter ECG monitoring (ms)

  6. Mean number of times per hour in which the change in consecutive normal sinus R-R intervals exceeds 50 milliseconds (PNN50)

    Time frame: Change in PNN50 (day 1 and day 3)

    Measured with a 72 hours Holter ECG monitoring (%)

  7. Low Frequency component of Heart Rate Variability (LF)

    Time frame: Change in low frequencies (day 1 and day 3)

    Measured with a 72 hours Holter ECG monitoring (ms^2)

  8. High Frequency component of Heart Rate Variability (HF)

    Time frame: Change in high frequencies (day 1 and day 3)

    Measured with a 72 hours Holter ECG monitoring (ms^2)

  9. Low to High Frequency Ratio of Heart Rate Variability (LF/HF)

    Time frame: Change in LF/HF (day 1 and day 3)

    Measured with a 72 hours Holter ECG monitoring

Other outcomes

  1. CRP

    Time frame: before and 1 to 3 days after the drug infusion

    (mg/L)

  2. Glomerular Filtration Rate

    Time frame: Before and 1 to 3 days after the drug infusion

    CKD-EPI (mL/min/1.73m2)

  3. Natremia

    Time frame: Change in Natremia (day 1 and day 3)

    mmol/L

  4. Kaliemia

    Time frame: Change in Kaliemia (day 1 and day 3)

    mmol/L

  5. Chloremia

    Time frame: Change in Chloremia (day 1 and day 3)

    mmol/L

Sponsors and collaborators

Lead sponsor

Elza Abdessater

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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