Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)

Completed

• Conditions: Cancer
• Interventions: Device: Zephyr Biopatch Device

• Registration Number: NCT01848912
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

The purpose of this study is to find a way of detecting infection earlier in patients receiving bone marrow transplant. This is accomplished by continuous individualized monitoring of heart rate, respiratory rate and temperature variability in this patient population. The investigators are collecting data to determine whether or not subtle differences in heart rate, respiratory rate and temperature will help physicians to detect infection earlier in order to begin faster treatment before a patient's condition deteriorates. Blood tests will also be performed to check for certain biomarkers that may indicate infection

Detailed Description

In this prospective observational study, patients receiving bone marrow transplant are selected for continuous monitoring of heart rate, respiratory and temperate variability. Data is collected as per standard practice using the Zephyr Biopatch device, a highly compact wireless monitor with two small gel electrodes, that is much more comfortable than previous belt/strap-based monitoring devices.

The patient is asked to wear the Zephyr Biopatch device for approximately 23 hours a day, beginning the day before he/she begins bone marrow transplant. The patient is asked to continue wearing the device for a period of up to 10 days or until he/she is no longer experiencing any fever. The Zephyr Biopatch device records heart rate, respiratory rate and temperature for calculation of heart rate variability (HRV), respiratory rate variability (RRV) and temperature variability (TV) using the Continuous Multiorgan Individualized Variability Analysis (CIMVATM) software engine. The variability outcomes will look at the presence, rapidity and severity of change in variability prior to the onset, diagnosis and treatment of infection. Bloodwork will also be performed to check for certain biomarkers that may indicate infection.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-08
• Primary Completion: 2022-05
• Study Completion: 2022-05
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

An expected prolonged period of neutropenia

• Completing bone marrow;
• Allogeneic and/or autologous transplants OR
• Induction chemotherapy

Exclusion Criteria

• Inability to obtain written informed consent from patient or legally authorized representative
• Ongoing treatment for active infection (not prophylaxis)
• Preexisting severe cardiopulmonary disease (defined as an EF 40%, FEV 40%,or interstitial lung disease with pulmonary fibrosis)
• On betablockers or calcium channel blockers
• Preexisting arrhythmia
• Permanent pacemaker
• Inability to speak neither English nor French

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone Marrow Transplant Patients	Zephyr Biopatch Device	-

Primary Outcome Measures

Name	Time	Method
Initiation or broadening of antibiotic for the purpose of treatment of infection	Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days

Secondary Outcome Measures

Name	Time	Method
Admission to ICU with organ failure or hospital	Patients are monitored for a period of up to 10 days or until their white blood cell count goes up, which could take an expected average of 20 days

Trial Locations

Locations (1)

Bone Marrow Transplant Clinic,The Ottawa Hospital, General Campus; 🇨🇦 Ottawa, Ontario, Canada