NCT03453931|CompletedDMC
Arrhythmias, Microalbuminuria and Corticosteroids
Arrhythmias, Heart Rate Variability and Microalbuminuria After Intravenous Corticosteroids: An Observational Study
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Arrhythmias, Heart Rate Variability and Microalbuminuria After Intravenous Corticosteroids: An Observational Study
Sponsor study identifier
observational
15
1 country
1
Study Start
January 10, 2018
Actual (reported)Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 10, 2018
Actual (reported)February 10, 2018
Actual (reported)March 5, 2018
Actual (reported)June 30, 2018
Actual (reported)June 30, 2018
Actual (reported)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)
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)
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)
Intravenous high dose corticosteroids
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospitalized patients who are starting high-dose corticotherapy in Hôpital Erasme (Brussels).
Erasme hospital
Brussels, 1070, Belgium
Marc Leeman, PhD
Université Libre de Bruxelles
15 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2018
First Posted
March 5, 2018
Study Start
January 10, 2018
Actual (reported)Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)Last Updated
November 7, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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