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

August 17, 2017 updated by: Johns Hopkins University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

-

Exclusion Criteria: Emergency surgery

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
rScO2 desaturation data collection
Time Frame: During Surgery
During Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charles W Hogue, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Multicenter NIRS Study

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