150 Participants Needed

Circulation Evaluation Techniques for Sepsis

(DAISY Trial)

AL
TH
Overseen ByTerra Hiller, MSN, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Denver Health and Hospital Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines new methods to predict outcomes for patients with sepsis, a serious condition resulting from the body's response to infection. Researchers use tools like sublingual microscopy (a small camera to examine under the tongue) and urine tests to study blood flow and cell health. Participants include patients with sepsis and individuals undergoing surgery with general anesthesia. Those battling sepsis or preparing for surgery might be eligible to join. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future sepsis care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these circulation evaluation techniques are safe for patients?

Research shows that the treatments in this study are generally safe and well-tolerated. Studies have found that Microscan Sublingual Microscopy is a safe and practical method for checking blood flow under the tongue in emergencies, unlikely to cause harm or discomfort to patients.

The Starling SV-Passive Leg Raise is another technique being tested. Research suggests that this method safely and effectively assesses how well the heart pumps blood, helping doctors determine the heart's response to fluids without risking patient safety.

For the Vexus Ultrasound Scoring, research has shown that using ultrasound to check blood flow and congestion does not cause serious side effects. It is considered a safe way to evaluate fluid levels in patients with sepsis.

Overall, these techniques have been used safely in other studies, suggesting they should be safe for participants in this trial.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to evaluate sepsis, a serious condition that currently relies heavily on standard methods like blood tests and clinical assessments. One of the unique aspects of this trial is the use of Microscan Sublingual Microscopy, which provides a close look at blood flow under the tongue, potentially offering earlier and more precise detection of circulatory issues. Additionally, the Starling SV Passive Leg Raise technique could give a better understanding of fluid responsiveness, which is crucial for managing sepsis patients effectively. By combining these innovative techniques with traditional urine collection and Vexus Ultrasound Scoring, this trial aims to enhance our understanding of sepsis and improve patient outcomes through more accurate and timely assessments.

What evidence suggests that these techniques are effective for evaluating circulation in sepsis?

This trial will compare different techniques for evaluating circulation in sepsis. Research has shown that examining blood flow in tiny vessels under the tongue, a method used in the trial's Microscan Sublingual Microscopy intervention, provides important information about sepsis. Poor blood flow in these small vessels often links to worse outcomes in sepsis patients. The Starling SV-Passive Leg Raise test, another intervention in this trial, helps doctors assess fluid levels and heart function during sepsis, guiding treatment and potentially improving patient outcomes. Vexus ultrasound scoring, also part of this trial, is a promising tool for managing fluid levels, though its ability to predict serious issues like kidney damage or death has shown mixed results. Overall, these tools offer valuable insights into managing sepsis, but more research is needed to fully understand their effectiveness.23467

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with sepsis or septic shock who need to be admitted to the hospital. It also includes a control group of adults undergoing elective surgery that requires intubation and general anesthesia.

Inclusion Criteria

I am 18 or older, diagnosed with sepsis or septic shock, and need hospital admission.
I am 18 or older and will have surgery under general anesthesia.

Exclusion Criteria

Currently pregnant
Incarcerated persons
I am under 18 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Control patients will have urine collection and sublingual microscopy performed when intubated. Septic patients will have urine collection, Passive Leg Raise, Ultrasound, and sublingual microscopy performed.

During hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring of Renal Replacement Therapy and survival rates.

90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Microscan Sublingual Microscopy
  • Starling SV- Passive Leg Raise
  • Urine Collection
  • Vexus Ultrasound Scoring
Trial Overview The study aims to understand how well handheld vital microscopy can predict outcomes in patients by looking at tiny blood vessels under the tongue and measuring substances in the urine that indicate blood vessel health.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Septic Patient InterventionsExperimental Treatment4 Interventions
Group II: Control Patient InterventionsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Denver Health and Hospital Authority

Lead Sponsor

Trials
106
Recruited
403,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Effects of Fluids on the Sublingual Microcirculation in SepsisThis systematic review of the evidence aims to collate studies examining the microcirculatory outcomes after a fluid bolus in patients with sepsis.
Sublingual microcirculatory assessment on admission ...Results showed that patients with lactate clearance > 0% had lower sepsis-related organ failure assessment scores and creatinine levels.
Assessment of sublingual microcirculation in critically ill patientsInadequate correction of microcirculatory variables has shown to be associated with adverse outcome in sepsis patients (48). Additionally, despite similar ...
Prognostic Value of Sublingual Microcirculation in SepsisConclusions: Sublingual microcirculation was worse among patients who died and patients with severe sepsis than among patients who survived and patients with ...
Microcirculation-guided resuscitation in sepsis: the next ...Alterations in sublingual microvascular perfusion were detected during sepsis and are associated with poor outcome. More importantly, sublingual videomicroscopy ...
Safety and feasibility of sublingual microcirculation ...The main finding from this study is that early sublingual microcirculatory monitoring in the ED is feasible and safe for patients with THS, and ...
A review of the application and potential of microcirculatory ...Hand-held intravital videomicroscopy enables direct, noninvasive evaluation of the sublingual microcirculation at the bedside.
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