Heart Rhythm After Intravenous Methylprednisolone Administration
Ključne riječi
Sažetak
Opis
The clinical status of patients was evaluated before each pulse, including blood pressure monitoring, glucose level monitoring and symptoms of infection. HR and BP was measured continuously for 3 consecutive days (the day before, the day of IVMP and the day after IVMP) during 1st, 6th and 12th IVMP pulse, using 24-hour Holter ECG and ABMP. Serum laboratory tests for potassium, epinephrine and norepinephrine were measured 3 times the day before and the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP. Additionally, urine samples for potassium were collected 5 times the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP.
Datumi
Posljednja provjera: | 04/30/2020 |
Prvo podneseno: | 05/04/2020 |
Predviđena prijava poslana: | 05/12/2020 |
Prvo objavljeno: | 05/17/2020 |
Posljednje ažuriranje poslano: | 05/12/2020 |
Posljednje ažuriranje objavljeno: | 05/17/2020 |
Stvarni datum početka studija: | 12/31/2010 |
Procijenjeni datum primarnog završetka: | 02/19/2020 |
Procijenjeni datum završetka studije: | 02/19/2020 |
Stanje ili bolest
Intervencija / liječenje
Drug: active, moderate-to-severe GO
Faza
Grupe ruku
Ruka | Intervencija / liječenje |
---|---|
active, moderate-to-severe GO Each participant received IVMP according to EUGOGO recommendations (cumulative dose of methylprednisolone 4.5 g, treatment duration 12 weeks in single weekly intravenous pulses, first 6 weeks 0.5g of IVMP, next 6 weeks 0.25g of IVMP). | Drug: active, moderate-to-severe GO |
Kriterij prihvatljivosti
Dobni uvjeti za studiranje | 18 Years Do 18 Years |
Spolovi koji ispunjavaju uvjete za studij | All |
Metoda uzorkovanja | Probability Sample |
Prihvaća zdrave volontere | Da |
Kriteriji | Inclusion Criteria: - active, moderate-to-severe GO according to EUGOGO classification - euthyroidism - completion of 12 IVMP pulses. Exclusion Criteria: - cardiovascular morbidity (such as chronic heart failure and/or coronary heart disease) - uncontrolled hypertension (defined as systolic blood pressure (SBP) more than 140 mmHg and/or diastolic blood pressure (DBP) more than 90 mmHg) - contraindications to IVMP therapy - previous GCs treatment in the last 6 months. |
Ishod
Primarne mjere ishoda
1. 24-hour Holter ECG Monitoring - 1st pulse mean HR [72 hours]
2. 24-hour Holter ECG Monitoring - 6th pulse mean HR [72 hours]
3. 24-hour Holter ECG Monitoring - 12th mean HR [72 hours]
Sekundarne mjere ishoda
1. Serum potassium levels Day 0 - Day 1 [48 hours]
2. Serum epinephrine levels Day 0 - Day 1 [48 hours]
3. Serum norepinephrine levels Day 0 - Day 1 [48 hours]
4. Urine potassium levels Day 0 [24 hours]
5. 72-hour ambulatory blood pressure monitoring (ABPM) - 1st pulse mean BP [72 hours]
6. 72-hour ambulatory blood pressure monitoring (ABPM) - 6th pulse mean BP [72 hours]
7. 72-hour ambulatory blood pressure monitoring (ABPM) - 12th pulse mean BP [72 hours]
Ostale mjere ishoda
1. Serum potassium levels Day 0 - Day 7 [7 days]
2. Serum potassium levels Day 0 - Day 2 [72 hours]
3. Serum epinephrine levels Day 0 - Day 7 [7 days]
4. Serum epinephrine levels Day 0 - Day 2 [72 hours]
5. Serum norepinephrine levels Day 0 - Day 7 [7 days]
6. Serum norepinephrine levels Day 0 - Day 2 [72 hours]
7. Urine potassium levels Day 1- Day 2 [48 hours]
8. Urine potassium levels Day 3 - Day 7 [5 days]