The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

Summary

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).

Conditions

• Surgery

Interventions

PROCEDURE

Routine Elective Surgery- In patient or out patient elective surgery

Participants will be undergoing routine planned surgeries.

DIAGNOSTIC_TEST

Blood test for genetic testing

Blood test to determine differences in genes which may affect how certain medications affect the participant. All patients will consent to collection of a blood sample for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk.

OTHER

Drug-genetic Profile

Profile describing drugs that may be high-risk, those that should be used with caution, or drugs that are favorable to use based on the participants genes.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• University of Chicago

  lead OTHER

Principal Investigators

• Peter O'Donnell · University of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-22

Primary Completion

2027-08-22

Completion

2027-08-22

Countries

• United States

Study Locations