Clinical trial NCT01848912: Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)
Official title: Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital Academic Medical Association
First posted: 2013-05-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Initiation or broadening of antibiotic for the purpose of treatment of infection
timeFrame: 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 outcomes:
measure: Admission to ICU with organ failure or hospital
timeFrame: 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
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Bone Marrow Transplant Clinic,The Ottawa Hospital, General Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Christopher Bredeson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Andrew Seely, MD, PhD
role: STUDY_DIRECTOR
affiliation: Ottawa Hospital Research Institute
name: Bill Cameron, MD, FRCPC
role: STUDY_CHAIR
affiliation: Ottawa Hospital Research Institute
name: Tim Ramsay, MSc, PhD
role: STUDY_CHAIR
affiliation: Ottawa Hospital Research Institute
name: Lauralyn McIntyre, MD MSc
role: STUDY_CHAIR
affiliation: Ottawa Hospital Research Institute
name: Lothar Huebsch, MD
role: STUDY_CHAIR
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