Perioperative/Postoperative ComplicationsNCT03531268
Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing
A study testing PGx Testing in people with Perioperative/Postoperative Complications, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- PGx Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2018to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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).
- Subjects who are not being prescribed 4 or more medications, or who are not receiving any of the medication categories noted in the inclusion criteria.
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02110
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
Potential subjects will participate in screening with a minimum of 4 days prior to their planned surgery. The study involves obtaining mouth swab samples for genetic testing and employing standardized measures for PGx testing of subjects preoperatively.
Study staff will pre-screen potential subjects scheduled at the preoperative center or on surgeons' operative schedules. The study team member will ask the treating clinician involved with the care of a patient for permission to speak to the patient. The physician or a member of the research staff will describe the study to potentially eligible patients and a study investigator will obtain consent. After meeting inclusion and exclusion criteria, subjects who agree to participate in the study will complete study questionnaires and provide a swab sample for PGx analysis.
Trained members of the research staff will obtain a buccal swab sample from each subject who has given informed consent to participate in study procedures. The buccal swab will be packaged and shipped to an outside laboratory for processing and the conduct of the PGx testing. The results of the PGx testing will be provided in a standardized report and sent back to the research staff conducting the study. Typically, the turn-around for shipping the sample and obtaining the results will be 4 days. The results will be available to the anesthesiologist prior to the patient's surgery.
Prior to the initiation of the scheduled surgery, the anesthesiologist will be asked to complete a questionnaire about the clinical utility of PGx testing for that subject. In the perioperative group of subjects for whom clinicians find clinical utility for PGx testing (experimental group), outcomes will be compared to the remaining subjects (control group) for whom PGx testing was felt not to have any clinical utility.
After surgery, there will be two assessment periods. Clinical outcomes and the quality of the subject's recovery from surgery will be assessed postoperatively at 24 hours +/-4 hours after surgery by directly interviewing each study subject and reviewing the electronic medical record. Additional assessments of subjects will be conducted by review of the electronic medical record at 30 days +/- 3 days postoperatively.
- Being tested
- PGx Testing
- Keywords
- Pharmacogenomic Analysis, Clinical Utility, Outcomes
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGx TestingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The day of surgery or the day prior
Secondary outcomes (13)
Intraoperative and postoperative use of opioids
The use of intraoperative and postoperative use of opioids will be measured (morphine mg equivalents)
Measured: 24 hrs +/- 4 hrs after surgery
Duration times (surgery, anesthesia, length of stay in PACU)
Surgical duration and anesthesia duration times, length of stay in PACU (duration will be measured in minutes)
Measured: 24 hrs +/- 4 hrs after surgery
Pain Assessment
Pain Numeric Rating Scale, 0 - 10 (0 = no pain, 10 = maximum pain) (lower values = better outcome)
Measured: 24 hrs +/- 4 hrs after surgery
Postoperative Nausea and Vomiting
Postoperative Nausea and Vomiting Scale (0 = no nausea/vomiting, 200 = maximal nausea/vomiting) (lower values = better outcome)
Measured: 24 hrs +/- 4 hrs after surgery
Sedation and Delirium Assessment
Richmond Agitation and Sedation Scale (-5 = unarousable, 0 = alert and calm, +4 = combative) (values = 0 are best outcome)
Measured: 24 hrs +/- 4 hrs after surgery
Subject Satisfaction
Subject Satisfaction Questionnaire (1 = extremely dissatisfied, 5 = extremely satisfied) (higher values = best outcome)
Measured: 24 hrs +/- 4 hrs after surgery
Quality of Recovery
Quality of Recovery Questionnaire (0 = poor, 150 = excellent) (higher values = best outcome)
Measured: 24 hrs +/- 4 hrs after surgery
Length of stay in hospital after surgery
Length of stay in the hospital after surgery (days)(lower number = best outcome)
Measured: 30 days
Opioid Prescriptions
Amount of opioids prescribed after surgery (morphine mg equivalents) (lower amount = best outcome)
Measured: 30 days
Hospital Readmissions
Number of times readmitted to hospital within 30 days after surgery (lower number = best outcome)
Measured: 30 days
Emergency Room Visits
Number of emergency room visits within 30 days after surgery (lower number = best outcome)
Measured: 30 days
Unscheduled Phone Calls
Number of unscheduled phone calls to the doctor's office within 30 days after surgery (lower number = best outcome)
Measured: 30 days
Unscheduled Office Visits
Number of unscheduled visits to the doctor's office within 30 days after surgery (lower number = best outcome)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start20 Oct 2018 (estimated)
- Primary completion20 May 2020 (estimated)
- Study completion20 May 2020 (estimated)
Why it stopped: Need improve the strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CQuentia NGS, LLC
- Responsible party
- Principal investigator, Srdjan Nedeljkovic, Brigham and Women's Hospital
- Investigators
- Srdjan S Nedeljkovic, MD, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531268
- Sponsor's protocol ID
- 2018P000454
- Status last verified
- Jan 2019
- First submitted
- 24 Apr 2018
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26516523Jannetto 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.
PubMed 19604091
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing
- ClinicalTrials.gov ID
- NCT03531268
- Acronym / sponsor ID
- 2018P000454
- Keywords
- Pharmacogenomic Analysis, Clinical Utility, Outcomes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Need improve the strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- CQuentia NGS, LLC
- Study start
- 20 Oct 2018 (estimated)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 21 May 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.
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.
Detailed description
Potential subjects will participate in screening with a minimum of 4 days prior to their planned surgery. The study involves obtaining mouth swab samples for genetic testing and employing standardized measures for PGx testing of subjects preoperatively.
Study staff will pre-screen potential subjects scheduled at the preoperative center or on surgeons' operative schedules. The study team member will ask the treating clinician involved with the care of a patient for permission to speak to the patient. The physician or a member of the research staff will describe the study to potentially eligible patients and a study investigator will obtain consent. After meeting inclusion and exclusion criteria, subjects who agree to participate in the study will complete study questionnaires and provide a swab sample for PGx analysis.
Trained members of the research staff will obtain a buccal swab sample from each subject who has given informed consent to participate in study procedures. The buccal swab will be packaged and shipped to an outside laboratory for processing and the conduct of the PGx testing. The results of the PGx testing will be provided in a standardized report and sent back to the research staff conducting the study. Typically, the turn-around for shipping the sample and obtaining the results will be 4 days. The results will be available to the anesthesiologist prior to the patient's surgery.
Prior to the initiation of the scheduled surgery, the anesthesiologist will be asked to complete a questionnaire about the clinical utility of PGx testing for that subject. In the perioperative group of subjects for whom clinicians find clinical utility for PGx testing (experimental group), outcomes will be compared to the remaining subjects (control group) for whom PGx testing was felt not to have any clinical utility.
After surgery, there will be two assessment periods. Clinical outcomes and the quality of the subject's recovery from surgery will be assessed postoperatively at 24 hours +/-4 hours after surgery by directly interviewing each study subject and reviewing the electronic medical record. Additional assessments of subjects will be conducted by review of the electronic medical record at 30 days +/- 3 days postoperatively.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PGx testing has clinical utility | Active comparator | Other: PGx TestingThese 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (6 listed)
- 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).
- Subjects who are not being prescribed 4 or more medications, or who are not receiving any of the medication categories noted in the inclusion criteria.
- 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.
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 |
|---|---|---|
| PGx TestingPharmacogenomic (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. | Other | PGx testing has clinical utility |
Primary outcome
Clinical Utility
Time frame: The day of surgery or the day prior
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.
13 secondary outcomes
Intraoperative and postoperative use of opioids
Time frame: 24 hrs +/- 4 hrs after surgery
Duration times (surgery, anesthesia, length of stay in PACU)
Time frame: 24 hrs +/- 4 hrs after surgery
Pain Assessment
Time frame: 24 hrs +/- 4 hrs after surgery
Postoperative Nausea and Vomiting
Time frame: 24 hrs +/- 4 hrs after surgery
Sedation and Delirium Assessment
Time frame: 24 hrs +/- 4 hrs after surgery
Subject Satisfaction
Time frame: 24 hrs +/- 4 hrs after surgery
Quality of Recovery
Time frame: 24 hrs +/- 4 hrs after surgery
Length of stay in hospital after surgery
Time frame: 30 days
Opioid Prescriptions
Time frame: 30 days
Hospital Readmissions
Time frame: 30 days
Emergency Room Visits
Time frame: 30 days
Unscheduled Phone Calls
Time frame: 30 days
Unscheduled Office Visits
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Background: PubMed 26516523Cregg 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.
- Background: PubMed 19604091Jannetto 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Srdjan S Nedeljkovic, MD study director
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PGx Testing in people with Perioperative/Postoperative Complications, run by Brigham and Women's Hospital at 2 sites 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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Utility (time frame: The day of surgery or the day prior). 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 NCT03531268, which also lists 2 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 17 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.