The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

NCT03729180 | Recruiting

• 2 other identifiers: IRB17-14221R01HG009938
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.

  To explore the feasibility and utility of implementing broad preemptive pharmacogenomic testing in the perioperative setting by determining the frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.

  5 years

• Rate of use of high-risk drugs in perioperative setting

  To determine the rate of use high-risk drugs (red or yellow pharmacogenomic risk) in the group of patients for whom pharmacogenomic results are available compared to their rate of use (without provider knowledge of pharmacogenomic risk designation) in the control arm.

  5 years

Secondary Outcomes (6)

• Rate of use of favorable drugs in perioperative setting

  5 years

• Occurrence of specific pharmacogenomically-informed adverse drug events

  5 years

• Pharmacogenomic result availability on pain management services in both arms using a research database for each patient

  5 years

• Comparison of pain scores on a 10 point scale

  5 years

• Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database

  5 years

Study Arms (3)

Pain Cohort

OTHER

Patients with a post-operative pain consult will be included in a pain sub-analysis to assess pain scores, pain therapy administration, and rate of opioid-induced adverse events.

Procedure: Routine Elective Surgery- In patient or out patient elective surgery; Diagnostic Test: Blood test for genetic testing; Other: Drug-genetic Profile

Pharmacogenomic (PGx) Arm [Randomization Arm 1]

EXPERIMENTAL

All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.

Procedure: Routine Elective Surgery- In patient or out patient elective surgery; Diagnostic Test: Blood test for genetic testing; Other: Drug-genetic Profile

Control Arm [Randomization Arm 2]

OTHER

All patients will undergo preemptive genotyping prior to their surgical procedure. Pharmacogenomic test results will not be made available to providers (standard of care). Genotyping results will be released to study providers (and patients) at the 6-month unblinding timepoint for patients in the control group.

Procedure: Routine Elective Surgery- In patient or out patient elective surgery; Diagnostic Test: Blood test for genetic testing

Interventions

Routine Elective Surgery- In patient or out patient elective surgery PROCEDURE

Participants will be undergoing routine planned surgeries.

Control Arm [Randomization Arm 2]; Pain Cohort; Pharmacogenomic (PGx) Arm [Randomization Arm 1]

Blood test for genetic testing DIAGNOSTIC_TEST

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.

Control Arm [Randomization Arm 2]; Pain Cohort; Pharmacogenomic (PGx) Arm [Randomization Arm 1]

Drug-genetic Profile OTHER

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.

Pain Cohort; Pharmacogenomic (PGx) Arm [Randomization Arm 1]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have planned elective surgical procedures at the University of Chicago
• Must be aged 18 years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (1)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (3)

• Truong TM, Apfelbaum JL, Danahey K, Schierer E, Ludwig J, George D, House L, Karrison T, Shahul S, Anitescu M, Choksi A, Hartman S, Knoebel RW, van Wijk XMR, Yeo KJ, Meltzer DO, Ratain MJ, O'Donnell PH. Pilot Findings of Pharmacogenomics in Perioperative Care: Initial Results From the First Phase of the ImPreSS Trial. Anesth Analg. 2022 Nov 1;135(5):929-940. doi: 10.1213/ANE.0000000000005951. Epub 2022 Feb 25.

  PMID: 35213469 DERIVED

• Truong TM, Apfelbaum JL, Schierer E, Danahey K, Borden BA, Karrison T, Shahul S, Anitescu M, Gerlach R, Knoebel RW, Meltzer DO, Ratain MJ, O'Donnell PH. Anesthesia providers as stakeholders to adoption of pharmacogenomic information in perioperative care. Pharmacogenet Genomics. 2022 Apr 1;32(3):79-86. doi: 10.1097/FPC.0000000000000455.

  PMID: 34570085 DERIVED

• Truong TM, Apfelbaum J, Shahul S, Anitescu M, Danahey K, Knoebel RW, Liebovitz D, Karrison T, van Wijk XMR, Yeo KJ, Meltzer D, Ratain MJ, O'Donnell PH. The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care. Clin Pharmacol Ther. 2019 Dec;106(6):1179-1183. doi: 10.1002/cpt.1567. Epub 2019 Aug 21. No abstract available.

  PMID: 31433489 DERIVED

MeSH Terms

Interventions

Hematologic Tests; Genetic Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Peter O'Donnell

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Clinical Trials Office

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: November 2, 2018
• Study Start: January 22, 2019
• Primary Completion (Estimated): August 22, 2027
• Study Completion (Estimated): August 22, 2027
• Last Updated: April 24, 2026

Record last verified: 2025-12

Locations

US (1)