Pilot Study of the Feasibility of Multicenter NIRS Data Collection and Interventions for Desaturation in Cardiac Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Charles W. Hogue, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01765504
First received: January 3, 2013
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

Using the 9 centers (Appendix B) involved with the planned multicenter NIRS comparative effectiveness trial the specific aims of this study are:

  1. To demonstrate the feasibility of collecting rScO2 data from patients undergoing cardiac surgery in a multicenter study design.
  2. To demonstrate the feasibility of using a standard algorithm for treating rScO2 desaturations during cardiac surgery in a multicenter study design.

Condition
Cardiac Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Feasibility of Multicenter NIRS Data Collection and Interventions for Desaturation in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • rScO2 desaturation data collection [ Time Frame: During Surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Brain injury after cardiac surgery is a chief source of patient mortality and healthcare costs and can significantly impair quality of life. Reducing the burden of this complication has wide public health implications. The broad manifestations of perioperative brain injury include stroke, delirium, and cognitive decline.5 All forms of injury are believed to result primarily from cerebral embolism and/or reduced cerebral blood flow (CBF). The risk for cerebral hypoperfusion is likely the highest during cardiopulmonary bypass (CPB), when mean arterial pressure (MAP) is kept low (~60 mmHg), particularly for patients who are aged and who have cerebral vascular disease. Near-infrared spectroscopy (NIRS) is used increasingly to monitor regional cerebral oxygen saturation (rScO2) in patients undergoing cardiac surgery, although limited data show that it improves patient outcomes. Regardless, clinical evidence supporting the efficacy of NIRS-based monitoring is needed urgently because the cost of NIRS sensors (~$220/patient) could add $132 million annually to hospital costs for cardiac surgery. We must address this issue quickly because the rising prevalence of NIRS use and advocacy by experts and industry will likely soon result in NIRS becoming a standard of care. We are in the process of submitting a multicenter, prospectively randomized comparative effectiveness trial to assess the efficacy of NIRS monitoring in patients who are undergoing coronary artery bypass graft (CABG) surgery with CPB, and/or valve surgery, and who are at risk for brain injury. The goal of the planned proposal is to determine whether interventions to correct rScO2 desaturations (value <50% or 20% reduction from room air baseline) reduce the frequency of neurologic and other complications compared with standard care (no clinical monitoring). In order to demonstrate feasibility of our proposal we need to demonstrate the ability of the team to collect rScO2 data from multiple centers and to show the ability of the team to properly follow an algorithm for treating rScO2 desaturations that occur during surgery. Thus, the aim of the current study is to collect preliminary data to support our larger comparative effectiveness trial.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient inclusion criteria will be male or female patients >50 years of age undergoing primary or re-operative CABG and/or cardiac valve surgery that requires CPB who will have NIRS monitoring for clinical indications.

Criteria

Inclusion Criteria: Patient inclusion criteria will be male or female patients >50 years of age undergoing primary or re-operative CABG and/or cardiac valve surgery that requires CPB who will have NIRS monitoring for clinical indications.

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Exclusion Criteria: Emergency surgery

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765504

Contacts
Contact: Charles W Hogue, MD 410-614-1516 chogue2@jhmi.edu
Contact: Michelle Parish, BSN, CCRC 410-955-7461 maparish@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Michelle Parish, BSN, CCRC    410-955-5461    maparish@jhmi.edu   
Principal Investigator: Charles W Hogue, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Charles W Hogue, MD The Johns Hopkins University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Charles W. Hogue, Professor of Anesthesiology & Critical Care Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01765504     History of Changes
Other Study ID Numbers: Multicenter NIRS Study
Study First Received: January 3, 2013
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Cardiac surgery; near infrared spectroscopy

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014