Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy

Not Applicable

Completed

• Conditions: Acute Myeloid Leukemia (AML)
• Interventions: Device: Remote monitoring of temperature

• Registration Number: NCT04081753
• Lead Sponsor: Augusta University

Brief Summary

Febrile neutropenic patients are at high risk for developing sepsis and other infections which often necessitates acute admission to the Intensive Care Unit (ICU) and are associated with high mortality. Neutropenic fever is a medical emergency and early detection of fever allows for prompt infectious work up. In this study, the investigators will collect pilot data from outpatients utilizing a remote outpatient continuous temperature monitoring device to compare the incidence of ICU admission and severe sepsis to historical data for prior patients who did not receive at home monitoring device.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Study Start: 2019-12-16
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients who have acute myeloid leukemia (AML) and are candidates for consolidation chemotherapy with high dose cytarabine (HiDAC) after successful remission induction chemotherapy

• Both male and female
• Age 18 years and older

Exclusion Criteria

Patients who have already developed febrile neutropenia during their hospitalization for their consolidative cycle of chemotherapy will not be eligible for monitoring for that cycle; however, these patients will be able to participate in subsequent cycle if they do not develop febrile neutropenia during their subsequent HiDAC hospitalization.

• If a patient is admitted to the hospital between cycles of chemotherapy for reasons other than febrile neutropenia or its sequelae, they will be taken off study for that cycle and data not collected while they are admitted

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMD Group	Remote monitoring of temperature	Temperature Monitoring Device Group - The interventional group, who will be given the temperature monitoring device and will be monitored remotely.

Primary Outcome Measures

Name	Time	Method
Change ICU admission	1 month	The interventional group will have changed in the number of ICU admission.
Change incidence of sepsis in interventional group	1 month	The interventional group will have changed rate of sepsis incidence.

Trial Locations

Locations (1)

Augusta University Medical Center; 🇺🇸 Augusta, Georgia, United States