Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Injury and Intraoperative Tissue Oximetry in Patients Undergoing Spine Surgery (MONITOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518372
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Myocardial injury after non-cardiac surgery (MINS) is common in patients undergoing major surgery. Many of the events are undetected and associated with a high 30-day mortality risk. Knowledge of which perioperative factors that predicts MINS is lacking. Decrease in tissue oxygenation (StO2) is common in patients undergoing major spine surgery and is associated with postoperative complications in these patients. However, an association between decrease in tissue oxygenation and MINS has not been examined. This group of patients may have other potential predictors of postoperative complications that the study group would like to investigate. In this observational cohort study, we will include 70 patients undergoing major spine surgery at University of California San Francisco. The primary hypothesis is that decrease in intraoperative tissue oxygenation is associated with postoperative myocardial injury.

Condition or disease
Hypoxia Myocardial Injury Surgery--Complications

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Myocardial Injury and Intraoperative Tissue Oximetry in Patients Undergoing Spine Surgery (MONITOR)
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : July 24, 2018
Actual Study Completion Date : July 24, 2018



Primary Outcome Measures :
  1. High-sensitivity Troponin T elevation [ Time Frame: Measurement done on first and second day after surgery (highest value of the two is used in the primary analysis) ]
    Peak value (the highest of two postoperative measurements) of high-sensitivity Troponin T (hsTnT) elevation (as assessment for myocardial injury).


Secondary Outcome Measures :
  1. Myocardial injury after non-cardiac surgery (MINS) [ Time Frame: Baseline prior to surgery (for adjustment), first and second day after surgery. ]
    Myocardial injury after non-cardiac surgery (MINS) assessed as a at least one postoperative hsTnT value of 14 ng/L or more. Two independent expert adjudicators will screen medical records for patients with troponin elevations for non-ischemic etiology of the elevation (e.g. sepsis or kidney failure).


Other Outcome Measures:
  1. Myocardial infarction [ Time Frame: Within 30 days after surgery ]
    Diagnosis of myocardial infarction from medical record

  2. Non-fatal cardiac arrest [ Time Frame: Within 30 days after surgery ]
    Diagnosis of non-fatal cardiac arrest from medical record

  3. Transient cerebral ischemia (TCI) [ Time Frame: Within 30 days after surgery ]
    Diagnosis of transient cerebral ischemia from medical record

  4. Overt stroke [ Time Frame: Within 30 days after surgery ]
    Diagnosis of overt stroke from medical record

  5. Mortality [ Time Frame: Within 30 days after surgery ]
    From medical record


Biospecimen Retention:   Samples With DNA
Blood samples: Plasma for high-sensitivity Troponin T analysis. Three samples in total: One baseline, one on first postoperative day and one on second postoperative day. Each samples is 4.5 mL.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Eligible patients are undergoing spine surgery at University of California, San Francisco at the Parnassus Campus.
Criteria

Inclusion Criteria:

  • Male or female ≥18 years
  • Patient is undergoing elective surgery of the spine
  • Surgery is scheduled to last ≥ 2 hours and involve instrumentation

Exclusion Criteria:

  • Patient is < 18 years
  • Patient is undergoing emergent or urgent surgery
  • American Society of Anesthesiologist (ASA) status > IV
  • Patient is undergoing non-instrumental surgery, such as laminectomy alone
  • Patient is undergoing spine surgery for tumor or infection

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): NCT03518372


Locations
Layout table for location information
United States, California
UCSF Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Phil Bickler, MD PhD University of California, San Francisco
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03518372    
Other Study ID Numbers: Tissue Oximetry and Troponin
IRB#14-12996 ( Other Identifier: Institutional Review Board )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Hypoxia
Myocardial Injury
Surgery--Complications
Tissue Oximetry
Near-infrared Spectroscopy (NIRS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoxia
Wounds and Injuries
Signs and Symptoms, Respiratory