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Completed

NCT Number: NCT01848912

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bone Marrow Transplant Clinic,The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zephyr Biopatch Device

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • The Ottawa Hospital Academic Medical Association

Registry information

Acronym: THRRIVES

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
May 8, 2013
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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