Actively Recruiting
Effects of Norepinephrine on Blood Flow and Tissue Perfusion in ICU Patients with Septic Shock
Led by Copenhagen University Hospital, Hvidovre · Updated on 2025-03-07
45
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
C
Copenhagen University Hospital, Hvidovre
Lead Sponsor
U
University Hospital Bispebjerg and Frederiksberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of norepinephrine, a common medication used to treat septic shock, on blood flow and tissue perfusion in adults. Septic shock can cause a mismatch between overall blood circulation and the actual delivery of blood to cells, and this study aims to better understand how norepinephrine influences these factors. This observational study will provide important insights to help tailor treatment based on individual patient needs. Participants in this study are adult patients with septic shock who are sedated and mechanically ventilated in intensive care units. The study involves carefully monitored adjustments to norepinephrine dosage, including stepwise reductions and increases, alongside fluid challenges to assess how these changes affect stroke volume and blood pressure. Extended monitoring equipment will be used to collect clinical and biochemical data, and tests like the passive leg raise will help predict fluid responsiveness. During the study, researchers will continuously measure stroke volume and cardiac output using various methods, including arterial waveform analysis and Doppler ultrasound. They will evaluate how changes in norepinephrine and fluid administration impact heart function and microcirculation over approximately one year. Safety checks and detailed monitoring are integral parts of the process, ensuring participant well-being while gathering data to improve management of septic shock.
CONDITIONS
Brief Title
Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected or documented infection
- Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg
- Serum lactate levels greater than 2 mmol/L
- Receiving norepinephrine infusion at a rate above 0.2 mcg/kg/min
- Adult patients aged 18 years or older
- Sedated and mechanically ventilated in the ICU
You will not qualify if you...
- Absolute contraindication for esophageal Doppler or urinary catheter insertion
- Severe valvular heart disease or cardiac arrhythmias causing severe instability
- Current treatment with lithium
- Use of other vasopressor or inotropic drugs
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 1 year
Participants undergo extended monitoring with equipment to collect clinical and biochemical parameters. Hemodynamic measurements are taken during stepwise reduction and increase of norepinephrine infusion and fluid challenges to assess blood flow and tissue perfusion.
Continuous monitoring during ICU stay
Trial Site Locations
Total: 1 location
1
Hvidovre Hospital
Hvidovre, Copenhagen, Denmark, 2665
Actively Recruiting
Research Team
H
Henrik Wolsted, MD
N
Nicolai Bang Foss, MD, DMsC
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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