Actively Recruiting
Can Perfusion Index Indicate the Need of Vasopressor in ICU Patients with Sepsis and Septic Shock Prospective Observational Study
Led by Ain Shams University · Updated on 2025-03-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Sepsis and septic shock are serious conditions with high mortality rates, often leading to low blood pressure due to damage to blood vessel lining. This research aims to explore the use of the perfusion index (PI), a noninvasive measurement from pulse oximetry, to provide reliable information about blood flow in small vessels during sepsis. The study seeks to understand how PI can guide the timing of starting vasopressor medications, which are used to raise blood pressure in these patients. This observational study monitors patients in intensive care units who have suspected sepsis or septic shock. Vasopressor drugs will be started only if patients do not improve after receiving fluids. PI will be measured at the start of resuscitation, just before vasopressor therapy, and at various times over 24 hours to assess peripheral blood flow. The study will not assign treatments but will observe and record patient responses and treatments as they occur. Participants will be evaluated with multiple measurements including PI, blood pressure, heart rate, blood gas levels, and oxygen saturation at baseline, shortly after fluid resuscitation, and repeatedly over 24 hours. Additional scores assessing illness severity and mortality at 28 days will be recorded. This approach helps researchers understand how PI relates to patient condition and treatment needs, with the study expected to continue until March 2025.
CONDITIONS
Brief Title
Observational Study About the Use of Perfusion Index to Use Vasopressor in Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All ICU patients with clinically suspected sepsis and septic shock
- Signs may include fever, hypotension, oliguria, and confusion combined with infection confirmed by culture
- Septic shock defined as persistent hypotension (mean arterial pressure 65 mm Hg) and elevated serum lactate level (>18 mg/dL [2 mmol/L]) not responding to fluid resuscitation
- Age 18 years or older
You will not qualify if you...
- Pregnant females
- Patients currently on vasopressor or positive inotropic drugs
- Patients with hypothermia (central temperature <356C)
- Patients with impaired upper extremity circulation (e.g., after radial artery harvesting or suspected arterial occlusion)
- Patients who had surgery involving large arteries of the aortic arch
- Patients with atherosclerosis
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 - 24 hours
Participants are observed with measurements of perfusion index and other hemodynamic parameters starting at resuscitation and continuing for 24 hours.
Measurements at baseline, 5 minutes after initial fluid resuscitation, and every 6 hours for 24 hours
Duration - 28 days
Participants are monitored for clinical outcomes including severity scores and mortality up to 28 days.
Follow-up assessments during the first 48 hours and mortality check at 28 days
Trial Site Locations
Total: 1 location
1
faculty of medicine Ain Shams University
Cairo, Egypt, 11757
Actively Recruiting
Research Team
N
Nancy Shaker ass.lecturer
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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