SurgeryNCT03729180
The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery
A study testing Routine Elective Surgery- In patient or out patient elective surgery, Blood test for genetic testing and Drug-genetic Profile in people with Surgery, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Routine Elective Surgery- In patient or out patient elective surgery, Blood test for genetic testing and Drug-genetic Profile
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 22 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who have planned elective surgical procedures at the University of Chicago
- Must be aged 18 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Emily Schierer, 773-753-1200, theimpresstrial@uchicago.edu
Peter O'Donnell, MD
About this study
Official title: 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.
Read more
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
- Being tested
- Routine Elective Surgery- In patient or out patient elective surgery, Blood test for genetic testing, Drug-genetic Profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Elective Surgery- In patient or out patient elective surgeryProcedure or surgery
Participants will be undergoing routine planned surgeries.
Blood test for genetic testingDiagnostic 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.
Drug-genetic ProfileOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Routine Elective Surgery- In patient or out patient elective surgery; Diagnostic Test: Blood test for genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Secondary outcomes (6)
Rate of use of favorable drugs in perioperative setting
To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.
Measured: 5 years
Occurrence of specific pharmacogenomically-informed adverse drug events
To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.
Measured: 5 years
Pharmacogenomic result availability on pain management services in both arms using a research database for each patient
To explore the effects of pharmacogenomic result availability on pain management services in both arms.
Measured: 5 years
Comparison of pain scores on a 10 point scale
To compare pain scores between both arms.
Measured: 5 years
Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database
To determine anesthesia and critical care providers' knowledge and perceptions of prescribing decisions in order to develop better genomic delivery systems in the future
Measured: 5 years
Differences in patient reported satisfaction using research database
To determine whether differences in patient-reported satisfaction and adherence likelihood are observable for patients whose providers access and use pharmacogenomic information.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start22 Jan 2019
- Primary completion22 Aug 2027 (estimated)
- Study completion22 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Peter O'Donnell, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729180
- Sponsor's protocol ID
- IRB17-1422
- Other IDs
- 1R01HG009938
- Status last verified
- Dec 2025
- First submitted
- 12 Oct 2018
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35213469Truong 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.
PubMed 34570085Truong 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.
PubMed 31433489
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care
- ClinicalTrials.gov ID
- NCT03729180
- Acronym / sponsor ID
- IRB17-1422
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 22 Aug 2027 (estimated)
- Study completion
- 22 Aug 2027 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Cohort | Other | Procedure: Routine Elective Surgery- In patient or out patient elective surgery, Diagnostic Test: Blood test for genetic testing, Other: Drug-genetic ProfilePatients 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. |
| Pharmacogenomic (PGx) Arm [Randomization Arm 1] | Experimental | Procedure: Routine Elective Surgery- In patient or out patient elective surgery, Diagnostic Test: Blood test for genetic testing, Other: Drug-genetic ProfileAll patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers. |
| Control Arm [Randomization Arm 2] | Other | Procedure: Routine Elective Surgery- In patient or out patient elective surgery, Diagnostic Test: Blood test for genetic testingAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who have planned elective surgical procedures at the University of Chicago
- Must be aged 18 years or older
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Elective Surgery- In patient or out patient elective surgeryParticipants will be undergoing routine planned surgeries. | Procedure or surgery | Control Arm [Randomization Arm 2], Pain Cohort, Pharmacogenomic (PGx) Arm [Randomization Arm 1] |
| Blood test for genetic testingBlood 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. | Diagnostic test | Control Arm [Randomization Arm 2], Pain Cohort, Pharmacogenomic (PGx) Arm [Randomization Arm 1] |
| Drug-genetic ProfileProfile 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. | Other | Pain Cohort, Pharmacogenomic (PGx) Arm [Randomization Arm 1] |
Primary outcome
The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.
Time frame: 5 years
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.
Rate of use of high-risk drugs in perioperative setting
Time frame: 5 years
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.
6 secondary outcomes
Rate of use of favorable drugs in perioperative setting
Time frame: 5 years
Occurrence of specific pharmacogenomically-informed adverse drug events
Time frame: 5 years
Pharmacogenomic result availability on pain management services in both arms using a research database for each patient
Time frame: 5 years
Comparison of pain scores on a 10 point scale
Time frame: 5 years
Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database
Time frame: 5 years
Differences in patient reported satisfaction using research database
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 35213469Truong 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.
- Derived from this study: PubMed 34570085Truong 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.
- Derived from this study: PubMed 31433489Truong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter O'Donnell principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Elective Surgery- In patient or out patient elective surgery, Blood test for genetic testing and Drug-genetic Profile in people with Surgery, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Clinical Trials Office (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03729180, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.