Corticosteroids Adverse ReactionNCT03453931
Arrhythmias, Microalbuminuria and Corticosteroids
An observational study of Corticosteroids Adverse Reaction, run by Elza Abdessater at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corticosteroids Adverse Reaction
- What is being tested?
- Corticosteroid injection
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jan 2018to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Hospitalized patients who are starting high-dose corticotherapy in Hôpital Erasme (Brussels).
Who may be able to join
- Starting high-dose intravenous corticotherapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Corticosteroid injection
- Keywords
- Corticosteroids, Arrhythmia, Heart Rate Variability, Albuminuria
- Medical subject headings
- Arrhythmias, Cardiac, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injectionDrug
Also called Solumedrol
Intravenous high dose corticosteroids
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmias
All types of arrhythmias (especially pauses and atrial fibrillation). Evaluated with a 72-hours Holter ECG monitoring
Measured: Change between day 1 and day 3
Microalbuminuria
Microalbuminuria (mg/dL)
Measured: Change in microalbuminuria (day 1 and day 3)
Microalbuminuria - Urinary Creatinine ratio
mg/g creatinine
Measured: Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3)
Secondary outcomes (9)
Baroreflex Sensitivity
Measured with a Finometer (ms/mmHg)
Measured: Change in Baroreflex Sensitivity (day 1 and day 3)
Beat-to-beat blood pressure
Measured with a Finometer (mmHg)
Measured: Change in beat-to-beat blood pressure (day 1 and day 3)
Heart Rate
Measured with a 72 hours Holter ECG monitoring (bpm)
Measured: 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)
Measured: 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)
Measured: 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 (%)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Change in LF/HF (day 1 and day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start10 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corticosteroids Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elza Abdessater
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elza Abdessater, Université Libre de Bruxelles
- Investigators
- Marc Leeman, PhD, Study director, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453931
- Sponsor's protocol ID
- P2017/556 / B406201734265
- Status last verified
- Nov 2023
- First submitted
- 10 Feb 2018
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmias, Heart Rate Variability and Microalbuminuria After Intravenous Corticosteroids: An Observational Study
- ClinicalTrials.gov ID
- NCT03453931
- Acronym / sponsor ID
- P2017/556 / B406201734265
- Conditions
- Corticosteroids Adverse Reaction
- Keywords
- Corticosteroids, Arrhythmia, Heart Rate Variability, Albuminuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Elza AbdessaterUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients who are starting high-dose corticotherapy in Hôpital Erasme (Brussels).
Key inclusion criteria (1 listed)
- Starting high-dose intravenous corticotherapy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid injectionAlso: SolumedrolIntravenous high dose corticosteroids | Drug | – |
Primary outcome
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
Microalbuminuria
Time frame: Change in microalbuminuria (day 1 and day 3)
Microalbuminuria (mg/dL)
Microalbuminuria - Urinary Creatinine ratio
Time frame: Change in microalbuminuria - urinary creatinine ratio (day 1 and day 3)
mg/g creatinine
9 secondary outcomes
Baroreflex Sensitivity
Time frame: Change in Baroreflex Sensitivity (day 1 and day 3)
Beat-to-beat blood pressure
Time frame: Change in beat-to-beat blood pressure (day 1 and day 3)
Heart Rate
Time frame: Change in Heart Rate (day 1 and day 3)
Standard Deviation of normal to normal R-R intervals (SDNN)
Time frame: Change in SDNN (day 1 and day 3)
Root Mean Square of the Successive Differences (RMSSD)
Time frame: 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)
Time frame: Change in PNN50 (day 1 and day 3)
Low Frequency component of Heart Rate Variability (LF)
Time frame: Change in low frequencies (day 1 and day 3)
High Frequency component of Heart Rate Variability (HF)
Time frame: Change in high frequencies (day 1 and day 3)
Low to High Frequency Ratio of Heart Rate Variability (LF/HF)
Time frame: Change in LF/HF (day 1 and day 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Leeman, PhD study director
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corticosteroids Adverse Reaction, run by Elza Abdessater at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmias (time frame: Change between day 1 and day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.