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

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ClinicalTrials.gov Identifier: NCT01848912
Recruitment Status : Active, not recruiting
First Posted : May 8, 2013
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
The Ottawa Hospital Academic Medical Association
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Cancer 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.


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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)
Study Start Date : March 2013
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : July 2019

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



Primary Outcome Measures :
  1. Initiation or broadening of antibiotic for the purpose of treatment of infection [ Time Frame: 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 :
  1. Admission to ICU with organ failure or hospital [ Time Frame: 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 ]

Biospecimen Retention:   Samples Without DNA
blood serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848912


Locations
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Canada, Ontario
Bone Marrow Transplant Clinic,The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Ottawa Hospital Academic Medical Association
Investigators
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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

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01848912     History of Changes
Other Study ID Numbers: 20120564-01H
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided