High versus low blood-pressure target in patients with septic shock.
Pierre Asfar, Ferhat Meziani, Jean-François Hamel...
https://pubmed.ncbi.nlm.nih.gov/24635770Actively Recruiting
Led by Mahidol University · Updated on 2025-04-27
60
Participants Needed
3
Research Sites
52 weeks
Total Duration
Researchers are evaluating the benefit of using dynamic arterial elastance (Eadyn) and Assisted Fluid Management (AFM) software to guide fluid and vasopressor therapy in patients with septic shock who are mechanically ventilated. Septic shock involves systemic inflammation causing low blood pressure and organ dysfunction, and managing fluids and vasopressors precisely is challenging. This pilot study compares the AFM and Eadyn-guided therapy to the standard care approach to see if it can reduce the time it takes for shock to reverse. The study has two groups: one receiving standard care based on septic shock guidelines including vasopressors like norepinephrine and fluid challenges guided by blood pressure and central venous pressure; the other group receives standard care plus AFM and Eadyn-guided treatment. This involves using a monitoring device to measure stroke volume changes and arterial elastance to guide fluid administration and vasopressor dosing every 10 minutes until blood pressure targets are met. Fluid therapy is adjusted based on specific predictions and arterial tone measurements. Participants will be assessed through invasive arterial pressure monitoring, echocardiograms, and clinical measures such as urine output, capillary refill time, and serum lactate levels. Researchers will track outcomes including time to shock reversal within 28 days, vasopressor dose and duration, fluid volume given, hospital length of stay, mortality, and kidney function measures. Safety and effectiveness data will be collected throughout the trial, which runs until April 2028.
CONDITIONS
Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours
Participants receive resuscitation for septic shock either guided by dynamic arterial elastance and assisted fluid management software or by the standard care according to septic shock guidelines. Treatment involves fluid therapy and vasopressor adjustments to achieve the target mean arterial pressure (MAP) of 65 mm Hg with continuous monitoring of tissue perfusion.
Continuous monitoring during ICU stay with frequent assessments
Duration - Up to 28 days
Participants are monitored for clinical outcomes including shock reversal, organ function, fluid accumulation, and survival for up to 28 days after treatment.
Assessments at multiple time points during hospital and ICU stay
Total: 3 locations
1
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Not Yet Recruiting
2
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Actively Recruiting
3
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Actively Recruiting
R
Ranistha Ratanarat, MD
N
Nuwara Pornawalai, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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