Lab Clasp Device for Sepsis Monitoring

GJ
PR
Overseen ByPeter R Chai, MD, MMS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
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 tests a new device called the Lab Clasp, resembling a pulse oximeter, to measure lactate levels noninvasively. Lactate levels provide doctors with information about stress or infection in the body, which is crucial for individuals with sepsis. The trial aims to determine if this device can accurately measure lactate from interstitial fluid (the fluid between cells) compared to the standard blood test. This advancement could simplify monitoring by reducing the need for repeated blood draws. Suitable participants have stable health without recent medication changes, no skin allergies to the device, and can provide blood samples.

As an unphased trial, this study offers an opportunity to contribute to innovative research that could simplify and improve patient care.

What prior data suggests that the Lab Clasp device is safe for sepsis monitoring?

Research has shown that the Lab Clasp device is designed to be noninvasive, similar to a finger pulse oximeter. This design likely poses less risk than methods requiring blood draws. One study aimed to match lactate readings from blood tests closely, demonstrating promise in accuracy and safety. The Lab Clasp avoids needles, reducing the risk of infection. This device could provide a safer, more comfortable method for monitoring lactate levels in people with sepsis. However, the device remains under study, and more data is needed to confirm its safety.12345

Why are researchers excited about this trial?

Researchers are excited about the Lab Clasp device for sepsis monitoring because it offers a new way to track the condition using a finger-based device. Unlike current options that might rely on blood tests, this device measures interstitial fluid lactate levels, which could provide quicker and potentially more accurate insights into a patient's condition. This innovative approach aims to enhance monitoring efficiency and may lead to faster interventions, which is crucial in managing sepsis effectively.

What evidence suggests that the Lab Clasp device is effective for sepsis monitoring?

Research has shown that monitoring lactate levels can aid in managing sepsis, a serious reaction to infection. One study found that treating sepsis patients based on their lactate levels led to better outcomes than other methods. In this trial, participants will use the Lab Clasp, a new device that measures lactate from the fluid around cells without needing to draw blood. It functions like a finger clip and quickly provides lactate readings. Unlike traditional methods requiring blood samples, the Lab Clasp offers a noninvasive option, making the process faster and easier.12467

Who Is on the Research Team?

GJ

Guruprasad Jambaulikar, MBBS, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 in good health, without recent medication changes or unstable medical issues. Participants must not have skin allergies to Lab Clasp materials, a history of serious illness like cancer or heart disease, poor veins for drawing blood, recent hospital stays, substance abuse problems, or be on certain medications like statins.

Inclusion Criteria

Willing to comply with all study procedures including providing venous blood samples at the CCI
Have no known skin allergy to the components of the Lab Clasp
Provide consent to participate in the study
See 1 more

Exclusion Criteria

Recent hospitalization within the past 30 days
You have used vaping or propylene glycol in the past.
You are generally in poor health and not physically strong.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Device Testing

Participants use the Lab Clasp device to measure interstitial fluid lactate values and compare them to venous lactate levels

150 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device testing

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lab Clasp

Trial Overview

The study tests the Lab Clasp device's ability to monitor sepsis risk by measuring lactate levels in interstitial fluid and comparing these readings with traditional venous blood samples. The goal is to validate this noninvasive method against the current clinical standard.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Lab ClaspExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Cambridge Medical Technologies, LLC

Industry Sponsor

Trials
3
Recruited
100+

Citations

A Validation Study of the Lab Clasp Device: A Point of Care ...

The primary outcome measure will be the average difference in lactate values between the Lab Clasp device and the reference (laboratory venous lactate) in ...

Lactate Monitoring in Intensive Care: A Comprehensive ... - PMC

Lactate-directed resuscitation has been shown to improve outcomes compared to central venous oxygen saturation-guided therapy in sepsis [24].

Impact of Point-of-Care Lactate Testing for Sepsis on ...

Conclusions: Bedside lactate POCT successfully reduced the time to obtain lactate results. Although lactate POCT did not lead to improved ...

(PDF) Impact of Point-of-Care Lactate Testing for Sepsis on ...

Conclusions: Bedside lactate POCT successfully reduced the time to obtain lactate results. Although lactate POCT did not lead to improved ...

Lactate Testing in Suspected Sepsis: Trends and Predictors of ...

Measuring lactate levels have been shown to risk stratify patients with suspected sepsis, to prompt aggressive early treatment, and to help monitor the impact ...

Lactate - An import marker for sepsis detection. ...

Increases in lactate may indicate organs or other tissue are not getting enough oxygen and is used to evaluate cause of acid/base disturbance. Lactic acid ...

Understanding the Lactate Test for Sepsis: Key Insights ...

When lactate values exceed 4 mmol/L, the risk of death in sepsis patients significantly increases.10