Pharmacogenomic Decision Making at Time of Surgery

  • Interventional
  • Not Recruiting
  • NCT03729180
Eligibility Details Visit Clinicaltrials.gov

The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care

The study is enrolling adults who are scheduled for either inpatient or outpatient elective surgical procedures at The University of Chicago. At pre-operative visits, patients will be consented and a blood sample will be obtained for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk. Genotyping results will be delivered to participating providers as patient-specific drug-gene clinical decision support summaries using a secured Web portal, the Genomic Prescribing System (GPS). Participating anesthesiologists and critical care and pain management physicians and associated providers from the Department of Anesthesia and Critical Care at the University of Chicago will be invited to receive results for their participating patients. There will be an initial 6- month "run-in" period of the study comprised of approximately 100 enrolled adults in which all patients will have pharmacogenomic results made available to providers. The run-in period will allow for process refinement and GPS delivery to be examined and optimized prior to the randomized phase After the initial run-in period, patients will be randomized to one of two arms - in the pharmacogenomic arm, providers will have access to GPS and pharmacogenomic information, whereas in the control arm, providers will not have access to GPS and patient-specific pharmacogenomic information (current standard of care).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
Accepts Healthy Volunteers

Inclusion Criteria:

         - Adult patients who have planned elective surgical procedures at the University of Chicago

         - Must be aged 18 years or older

        Exclusion Criteria:

         - Patients who have undergone, or are being actively considered for, liver or kidney transplantation

         - Patients with known active or prior leukemia.

         - Inability to understand and give informed consent to participate.

At a Glance

National Government IDNCT03729180

IRB#IRB17-1422

Lead SponsorUniversity of Chicago

Lead PhysicianPeter H. O'Donnell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting