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New treatment option for Supraventricular Arrhythmia
Official title Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04844801
What this study is testing
- What it's testing
- New-onset supraventricular arrhythmia (NOSVA) is reported in 40 % of patients with septic shock and is associated with hemodynamic alterations and mortality. The lack of consensus regarding best practices for the management of NOSVA in this setting has led to major variations in practice patterns.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>= 18 years
- Septic shock, defined by the association of the following criteria:
- Documented or suspected infection, with initiation of antibiotic therapy
- Initiation of vasopressors (norepinephrine, epinephrine) for at least 1 hour to maintain the MAP \> 65 mmHg
- NOSVA with heart rate ≥ 110 bpm lasting 5 minutes or more
You likely can't join if
- Refractory shock defined by a dose of noradrenaline BASE or adrenaline BASE \> 1.2 µg/kg/min
- Cardiac surgery or cardiac transplant in the previous month
- Aortic or mitral mechanical prosthesis, significant mitral stenosis (mitral surface \< 1.5 cm2)
- Congenital heart disease other than bicuspid aortic valve, atrial defect or patent foramen ovale.
- History of supraventricular arrhythmia prior to the episode of septic shock defined by a permanent TRSVN or paroxysmal TRSVN requiring long-term...
- NOSVA that began more than 48 hours ago \ (or more than 24 hours ago under vasopressor). \ In cases of TRSVN dating back more than 48 hours, the...
See the full eligibility criteria
- Age \>= 18 years
- Septic shock, defined by the association of the following criteria:
- Documented or suspected infection, with initiation of antibiotic therapy
- Initiation of vasopressors (norepinephrine, epinephrine) for at least 1 hour to maintain the MAP \> 65 mmHg
- NOSVA with heart rate ≥ 110 bpm lasting 5 minutes or more
- Written informed consent (patient, next of skin or emergency situation)
- Affiliation to a social security system
- Refractory shock defined by a dose of noradrenaline BASE or adrenaline BASE \> 1.2 µg/kg/min
- Cardiac surgery or cardiac transplant in the previous month
- Aortic or mitral mechanical prosthesis, significant mitral stenosis (mitral surface \< 1.5 cm2)
- Congenital heart disease other than bicuspid aortic valve, atrial defect or patent foramen ovale.
- History of supraventricular arrhythmia prior to the episode of septic shock defined by a permanent TRSVN or paroxysmal TRSVN requiring long-term specific treatment (heart rate reducer and/or antiarrhythmic and/or...
- NOSVA that began more than 48 hours ago \ (or more than 24 hours ago under vasopressor). \ In cases of TRSVN dating back more than 48 hours, the patient may be included after undergoing a transesophageal echocardiogram...
- Electrical cardioversion or use of amiodarone, other antiarrhythmic, or drug inducing bradycardia (beta-blockers, bradycardic calcium channel blocker, digitalis, flécaïnamide) in the previous 6 hours before inclusion
- Contraindication to amiodarone: history of serious adverse event related to amiodarone, history of lung disease related to amiodarone, history of hyperthyroidism related to amiodarone, PR interval \> 240 ms, severe...
- Kalemia \< 3 mmol/L
- Pregnant or breast feeding women
- Moribund patient or death expected from underlying disease during the current admission; Patient deprived of liberty and persons subject to institutional psychiatric care
- Participation to another treatment trial on septic shock and/or arrhythmic disease
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.