Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing

NCT03531268 | Withdrawn DMC

• 1 other identifier: 2018P000454
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Perioperative/Postoperative Complications

Keywords

Pharmacogenomic Analysis; Clinical Utility; Outcomes

Outcome Measures

Primary Outcomes (1)

• Clinical Utility

  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 = significant utility. The larger value (2) is considered as having a higher utility for this scale.

  The day of surgery or the day prior

Secondary Outcomes (13)

• Intraoperative and postoperative use of opioids

  24 hrs +/- 4 hrs after surgery

• Duration times (surgery, anesthesia, length of stay in PACU)

  24 hrs +/- 4 hrs after surgery

• Pain Assessment

  24 hrs +/- 4 hrs after surgery

• Postoperative Nausea and Vomiting

  24 hrs +/- 4 hrs after surgery

• Sedation and Delirium Assessment

  24 hrs +/- 4 hrs after surgery

Study Arms (2)

PGx testing has clinical utility

ACTIVE COMPARATOR

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.

Other: PGx Testing

PGx testing has no clinical utility

NO INTERVENTION

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.

Interventions

PGx Testing OTHER

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.

PGx testing has clinical utility

Eligibility Criteria

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

You may qualify if:

• Adults 18 years of age or older at screening.
• Adults with qualifying insurance coverage.
• Subjects scheduled to undergo elective surgery with an expected hospitalization 24 hrs =/- 4 hrs after surgery.
• American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
• 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.
• Able to provide informed consent, adhere to the study protocol, and complete all study assessments.

You may not qualify if:

• Subjects who do not have insurance coverage for PGx testing.
• 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).
• Planned multiple surgical procedures within the 30-day study follow up period.
• 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.
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• CQuentia NGS, LLC: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02110, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Srdjan S Nedeljkovic, MD

  Brigham and Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Associate Professor of Anaesthesia

Model Details: All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. The group for which testing is thought to have clinical utility will be compared to the group for which testing is thought to have no clinical utility.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 21, 2018
• Study Start: October 20, 2018
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)