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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 15 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two heart monitoring devices, NICOM and FloTrac, to see which better predicts if patients in septic shock need more fluids. FloTrac has undergone several software upgrades to improve its accuracy in various clinical settings. It focuses on patients who are critically ill and already receiving medication to support their blood pressure. The devices check how well the heart pumps blood when legs are raised or extra fluids are given. This helps doctors decide if giving more fluids will help the patient's heart work better.
Eligible Conditions
- Sepsis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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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