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

NCT01848912 | Completed

• 1 other identifier: 20120564-01H
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Bone Marrow Transplant Patients

Device: Zephyr Biopatch Device

Interventions

Zephyr Biopatch Device DEVICE

Bone Marrow Transplant Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• An expected prolonged period of neutropenia
• Completing bone marrow;
• Allogeneic and/or autologous transplants OR
• Induction chemotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

Bone Marrow Transplant Clinic,The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Neoplasms

Study Officials

• Christopher Bredeson, MD, MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Andrew Seely, MD, PhD

  Ottawa Hospital Research Institute

  STUDY DIRECTOR

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 8, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CA (1)