Using a non-invasive monitor to guide fluid treatment for patients with low blood pressure and septic shock
Pilot Evaluation Using The Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock
This study is testing a new non-invasive monitor to see if it can help doctors give the right amount of fluids to adults with low blood pressure due to septic shock.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 876 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05630716 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Non-Invasive Cardiac Output Monitor (NICOM) technology for guiding fluid resuscitation in adult inpatients experiencing sepsis-related hypotension or septic shock. The NICOM measures cardiac output and stroke volume dynamically, allowing for real-time assessment of fluid needs based on patient response to fluid administration. By comparing stroke volume before and after fluid challenges, the study aims to improve patient outcomes through more targeted fluid management. The approach seeks to replace traditional static measures of fluid needs with a more responsive and accurate method.
Who should consider this trial
Good fit: Ideal candidates are adult inpatients over 18 years old who meet the criteria for sepsis or septic shock.
Not a fit: Patients who are in comfort care or hospice, or those who die within 24 hours of admission, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fluid management and outcomes for patients with sepsis and septic shock.
How similar studies have performed: Other studies have shown promise in using dynamic monitoring technologies for fluid management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult patients \> 18 years of age * inpatients for \>/= 6 hours * meeting criteria for sepsis as defined by hypotension related to sepsis (MAP \< 65 or SBP \< 90) or evidence of septic shock (Lactate ≥ 4.0). Exclusion Criteria: * Patients who die within 24 hours of hospital admission * patients documented as "comfort cares" or enrolled in "general inpatient hospice" during the first 72 hours of hospitalization. * opted out of having their medical information used in research, as noted in the EHR.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Dichter, MD — University of Minnesota
- Study coordinator: Jeffrey Dichter, MD
- Email: jdichter@umn.edu
- Phone: 612-624-0999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.