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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Zephyr Biopatch Device

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 Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Bone Marrow Transplant Clinic,The Ottawa Hospital, General Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an expected prolonged period of neutropenia completing bone marrow transplant (including both allogeneic and autologous) or induction chemotherapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bone Marrow Transplant Patients	Device: Zephyr Biopatch Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Ottawa Hospital Academic Medical Association
• Investigators: Principal Investigator: Christopher Bredeson, MD, MSc, Ottawa Hospital Research Institute; Study Director: Andrew Seely, MD, PhD, Ottawa Hospital Research Institute; Study Chair: Bill Cameron, MD, FRCPC, Ottawa Hospital Research Institute; Study Chair: Tim Ramsay, MSc, PhD, Ottawa Hospital Research Institute; Study Chair: Lauralyn McIntyre, MD MSc, Ottawa Hospital Research Institute; Study Chair: Lothar Huebsch, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (ESTIMATE): May 8, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20120564-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED