Actively Recruiting
Cardiac Effects of Norepinephrine After the Initial Phase of Septic Shock
Led by CHU de Reims · Updated on 2024-08-22
49
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of norepinephrine on heart function in adults with septic shock lasting 24 hours or more. They want to understand how norepinephrine affects the heart's ability to pump blood after the initial critical phase of septic shock. This study focuses on the changes in heart performance despite possible alterations in heart receptor responses that may reduce drug effects over time. The study involves measuring heart function using transthoracic echocardiography (TTE) at two key times. First, clinical and biological parameters along with heart imaging are collected at baseline (T0). Then, after the doctor increases norepinephrine to reach a target mean arterial pressure (MAP) of 65 mmHg or higher (T1), these measurements are repeated to assess changes. The heart measurements include left ventricular ejection fraction, cardiac output, and other detailed heart function parameters. Participants will have vital signs, blood tests, and heart ultrasounds during the study. The main outcome is the change in left ventricular ejection fraction after norepinephrine dose adjustment. Data collection occurs shortly after reaching the MAP target, about 30 minutes on average. The study is observational, and participant involvement includes standard care monitoring alongside study assessments. Safety decisions like do-not-resuscitate orders are considered in eligibility.
CONDITIONS
Brief Title
Cardiovascular Effects of Norepinephrine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients older than 18 years
- Diagnosed with septic shock for at least 24 hours
- Mean arterial pressure below 65 mmHg requiring increased norepinephrine as decided by doctor
You will not qualify if you...
- Currently receiving Dobutamine treatment
- Pregnant individuals
- Patients with do-not-resuscitate orders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours or more after septic shock diagnosis
Participants have clinical circulatory and biological parameters collected as part of usual care, including transthoracic echocardiography (TTE) to evaluate heart function.
1 visit (in-person)
Duration - Approximately 30 minutes after norepinephrine dose increase
Participants are monitored after the clinician increases norepinephrine dose to achieve a target mean arterial pressure (MAP) of 65 mmHg, with repeated clinical, biological, and TTE assessments.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Chu Reims
Reims, France, 51092
Actively Recruiting
Research Team
O
Olfa Hamzaoui
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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