Boston, Massachusetts 02110

  • Perioperative/Postoperative Complications

Purpose:

In the perioperative realm, studies have demonstrated an association of genotype with efficacy of medications applicable to the surgical setting. A clinical association exists between the genotype of various genes and with opioid efficacy and toxicity - specifically for drugs such as oxycodone, codeine, morphine, fentanyl, and tramadol. More studies are needed to assess the effects of personalized dosing of analgesics during the perioperative process for various surgical procedures. The application of Pharmacogenomic testing (PGx) to perioperative medicine is novel, has much potential for growth and may potentially improve outcomes. However, successful implementation of a system to evaluate PGx and integrate results into clinical decision-making is challenging and has not been adequately assessed. The investigators propose to conduct PGx testing for patients undergoing surgery, evaluate its clinical utility, and assess outcomes. The investigators hypothesize that PGx testing may ultimately lead to a decrease in adverse events and improved outcomes in the perioperative period.


Study summary:

Potential subjects will participate in screening with a minimum of 4 days prior to their planned surgery. The study involves obtaining mouth swab samples for genetic testing and employing standardized measures for PGx testing of subjects preoperatively. Study staff will pre-screen potential subjects scheduled at the preoperative center or on surgeons' operative schedules. The study team member will ask the treating clinician involved with the care of a patient for permission to speak to the patient. The physician or a member of the research staff will describe the study to potentially eligible patients and a study investigator will obtain consent. After meeting inclusion and exclusion criteria, subjects who agree to participate in the study will complete study questionnaires and provide a swab sample for PGx analysis. Trained members of the research staff will obtain a buccal swab sample from each subject who has given informed consent to participate in study procedures. The buccal swab will be packaged and shipped to an outside laboratory for processing and the conduct of the PGx testing. The results of the PGx testing will be provided in a standardized report and sent back to the research staff conducting the study. Typically, the turn-around for shipping the sample and obtaining the results will be 4 days. The results will be available to the anesthesiologist prior to the patient's surgery. Prior to the initiation of the scheduled surgery, the anesthesiologist will be asked to complete a questionnaire about the clinical utility of PGx testing for that subject. In the perioperative group of subjects for whom clinicians find clinical utility for PGx testing (experimental group), outcomes will be compared to the remaining subjects (control group) for whom PGx testing was felt not to have any clinical utility. After surgery, there will be two assessment periods. Clinical outcomes and the quality of the subject's recovery from surgery will be assessed postoperatively at 24 hours +/-4 hours after surgery by directly interviewing each study subject and reviewing the electronic medical record. Additional assessments of subjects will be conducted by review of the electronic medical record at 30 days +/- 3 days postoperatively.


Criteria:

Inclusion Criteria: 1. Adults 18 years of age or older at screening. 2. Adults with qualifying insurance coverage. 3. Subjects scheduled to undergo elective surgery with an expected hospitalization 24 hrs =/- 4 hrs after surgery. 4. American Society of Anesthesiology (ASA) physical status 1, 2, or 3. 5. One or more of the following: - Subjects prescribed 4 or more medications at time of surgery. - Any subject prescribed any one of the following medication categories: opioid, benzodiazepine, antidepressant, antipsychotic, stimulant, mood stabilizer, NSAIDs, anti-epileptic drugs. - Any subject prescribed any one of the following medication categories: antiplatelet therapy, anticoagulant drugs. 6. Able to provide informed consent, adhere to the study protocol, and complete all study assessments. Exclusion Criteria: 1. Subjects who do not have insurance coverage for PGx testing. 2. Subjects who are expected to have surgery prior to the ability to obtain the results of the pharmacogenomic testing (generally it takes 4 days to obtain the results of testing). 3. Subjects who are not being prescribed 4 or more medications, or who are not receiving any of the medication categories noted in the inclusion criteria. 4. Planned multiple surgical procedures within the 30-day study follow up period. 5. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease that would cause the subject to be unable to comply with the study requirements. 6. Administration of an investigational drug within 30 days prior to providing PGx testing, or planned administration of an investigational product during the subject's participation in this study


Study is Available At:


Original ID:

2018P000454


NCT ID:

NCT03531268


Secondary ID:


Study Acronym:


Brief Title:

Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing


Official Title:

Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:

Need improve the strategy


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Srdjan S Nedeljkovic, MD
Study Director
Brigham and Women's Hospital

Study Dates

Start Date:October 20, 2018
Completion Date:May 20, 2020
Completion Type:Anticipated
Primary Completion Date:May 20, 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 15, 2019
First Received Date:April 24, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clinical Utility
Time Frame:The day of surgery or the day prior
Safety Issues:False
Description:The anesthesiologist will be shown the results of PGx testing and will complete a "Clinical Utility Questionnaire" regarding the clinical utility of PGx testing for the subject. The responses will be rated: 0 = no utility; 1 = some utility; 2 = significan
Outcome Type:Secondary Outcome
Measure:Intraoperative and postoperative use of opioids
Time Frame:24 hrs +/- 4 hrs after surgery
Safety Issues:False
Description:The use of intraoperative and postoperative use of opioids will be measured (morphine mg equivalents)
Outcome Type:Secondary Outcome
Measure:Duration times (surgery, anesthesia, length of stay in PACU)
Time Frame:24 hrs +/- 4 hrs after surgery
Safety Issues:False
Description:Surgical duration and anesthesia duration times, length of stay in PACU (duration will be measured in minutes)
Outcome Type:Secondary Outcome
Measure:Pain Assessment
Time Frame:24 hrs +/- 4 hrs after surgery
Safety Issues:False
Description:Pain Numeric Rating Scale, 0 - 10 (0 = no pain, 10 = maximum pain) (lower values = better outcome)
Outcome Type:Secondary Outcome
Measure:Postoperative Nausea and Vomiting
Time Frame:24 hrs +/- 4 hrs after surgery
Safety Issues:False
Description:Postoperative Nausea and Vomiting Scale (0 = no nausea/vomiting, 200 = maximal nausea/vomiting) (lower values = better outcome)
Outcome Type:Secondary Outcome
Measure:Sedation and Delirium Assessment
Time Frame:24 hrs +/- 4 hrs after surgery
Safety Issues:False
Description:Richmond Agitation and Sedation Scale (-5 = unarousable, 0 = alert and calm, +4 = combative) (values = 0 are best outcome)
Outcome Type:Secondary Outcome
Measure:Subject Satisfaction
Time Frame:24 hrs +/- 4 hrs after surgery
Safety Issues:False
Description:Subject Satisfaction Questionnaire (1 = extremely dissatisfied, 5 = extremely satisfied) (higher values = best outcome)
Outcome Type:Secondary Outcome
Measure:Quality of Recovery
Time Frame:24 hrs +/- 4 hrs after surgery
Safety Issues:False
Description:Quality of Recovery Questionnaire (0 = poor, 150 = excellent) (higher values = best outcome)
Outcome Type:Secondary Outcome
Measure:Length of stay in hospital after surgery
Time Frame:30 days
Safety Issues:False
Description:Length of stay in the hospital after surgery (days)(lower number = best outcome)
Outcome Type:Secondary Outcome
Measure:Opioid Prescriptions
Time Frame:30 days
Safety Issues:False
Description:Amount of opioids prescribed after surgery (morphine mg equivalents) (lower amount = best outcome)
Outcome Type:Secondary Outcome
Measure:Hospital Readmissions
Time Frame:30 days
Safety Issues:False
Description:Number of times readmitted to hospital within 30 days after surgery (lower number = best outcome)
Outcome Type:Secondary Outcome
Measure:Emergency Room Visits
Time Frame:30 days
Safety Issues:False
Description:Number of emergency room visits within 30 days after surgery (lower number = best outcome)
Outcome Type:Secondary Outcome
Measure:Unscheduled Phone Calls
Time Frame:30 days
Safety Issues:False
Description:Number of unscheduled phone calls to the doctor's office within 30 days after surgery (lower number = best outcome)
Outcome Type:Secondary Outcome
Measure:Unscheduled Office Visits
Time Frame:30 days
Safety Issues:False
Description:Number of unscheduled visits to the doctor's office within 30 days after surgery (lower number = best outcome)

Study Interventions

Intervention Type:Other
Name:PGx Testing
Description:Pharmacogenomic (PGx) testing will be administered to all subjects. The results of PGx testing will be evaluated for clinical utility. Subjects will be evaluated based on whether PGx testing has clinical utility or has no clinical utility.
Arm Name:PGx testing has clinical utility

Study Arms

Study Arm Type:Active Comparator
Arm Name:PGx testing has clinical utility
Description:These are subjects whose PGx testing is judged to have clinical utility and whose clinical care may be modified. Modifications may include altering doses or types of drugs given based on metabolic profile of the patient.
Study Arm Type:No Intervention
Arm Name:PGx testing has no clinical utility
Description:These are subjects whose PGx testing is judged to have no clinical utility. Care "as usual" is provided, and there are no changes in drug selection or dosing based on the results of PGx testing.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:CQuentia NGS, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Cregg R, Russo G, Gubbay A, Branford R, Sato H. Pharmacogenetics of analgesic drugs. Br J Pain. 2013 Nov;7(4):189-208. doi: 10.1177/2049463713507439.
PMID:26516523
Reference Type:Reference
Citation:Jannetto PJ, Bratanow NC. Utilization of pharmacogenomics and therapeutic drug monitoring for opioid pain management. Pharmacogenomics. 2009 Jul;10(7):1157-67. doi: 10.2217/pgs.09.64.
PMID:19604091

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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