Infectious Disease Clinical Trials
Home and Outpatient Monitoring of Elevated Lactate (HOME-L): Evaluating Continuous Lactate Monitor Sensor Use in Acute and Home Settings
What is the purpose of this study?
The objective of this study is to gather lactate sensor data from subjects discharged from a sepsis hospitalization. The correlation between lactate levels in interstitial fluid and physiologic data, collected from an activity tracker such as Fitbit, will be examined. The aim is to assess whether the data from the sensors can be utilized for continuous monitoring of hyperlactatemia after a sepsis hospitalization discharge at home and to identify evidence suggesting that continuous lactate monitoring could assist in early detection of deterioration, and/or reducing the likelihood of readmission.
Eligibility
Subjects must meet all of the following inclusion criteria to be considered eligible for participation in the study: 1. Subject must be at least 18 years of age. 2. Prior to enrollment, subject must meet sepsis criteria for sepsis, or severe sepsis, or septic shock (refer to Table 5 or Appendix 1) during their current hospital stay (either at admission or later) as adjudicated by a physician. This diagnosis must be related to the hospitalization from which the patient is being discharged. 3. In the investigator’s opinion, the subject must be able to follow the instructions provided by the study site and perform all study tasks as specified by the protocol, including, but not limited to: o Wearing an activity tracker (e.g., Fitbit) and CLM sensors for the whole duration of the study. o Compliance with sensor replacement schedule by the subject or willingness to travel to the site for sensor replacement by the site staff. o Compliance with smartphone management including regular charging and returning it to the site at the end of the study. 4. Subjects must be willing and able to provide written signed and dated informed consent. 5. Subject must have stable living conditions with continuous access to electricity and wireless internet.
Subjects must not meet exclusion criteria to be considered eligible for participation in the study. Subjects who meet any of the following criteria must be excluded from the clinical study:
1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
2. Subject must not be discharged directly to nursing home (residential aged care home/rest home/long-stay hospitals) after hospitalization.
3. Subjects who are currently pregnant (must be confirmed by pregnancy test taken by all subjects capable of becoming pregnant at or prior to enrolment).
4. Subjects who are breastfeeding a child.
5. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial lactate measurements. Such conditions include, but are not limited to, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection, or edema.
6. Subject is currently participating in another interventional (pharmacological) clinical trial.
7. Subject has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
8. Subject is unsuitable for participation due to any other cause determined by the investigator.
Where can I participate?
What is the full name of this Clinical Trial?
Home and Outpatient Monitoring of Elevated Lactate (HOME-L): Evaluating Continuous Lactate Monitor Sensor Use in Acute and Home Settings
- Disease Type/ConditionSepsis
- Principal InvestigatorPhilip A. Robinson, MD
- Age GroupAdult
- PhaseN/A
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org