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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All adult patients with severe sepsis or septic shock, who have arterial catheter placed with FloTrac monitor, with or without a central venous catheter.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Study Summary
This study is evaluating whether a noninvasive cardiac output monitor can be used to predict fluid responsiveness in patients with sepsis and septic shock.
Eligible Conditions
- Sepsis
- Septic Shock
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge
Secondary outcome measures
Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices
Trial Design
1Treatment groups
Experimental Treatment
Group I: NICOM/FloTracExperimental Treatment2 Interventions
500-1000ml Crystalloid fluid challenge (normal saline or plasmalyte) to be given for positive passive leg raise test by either device, and also will be given at baseline, regardless of baseline PLR response.
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Who is running the clinical trial?
Santa Barbara Cottage HospitalLead Sponsor
11 Previous Clinical Trials
428 Total Patients Enrolled
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