Acute PainNCT02605343
Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures
An observational study of Acute Pain and Surgery, run by AltheaDx at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process for patients undergoing bowel surgery, major urologic procedure, or major ventral hernia repair and requiring post-operative acute pain management in an inpatient basis, as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Surgery
- What is being tested?
- NeuroIDgenetix Test Panel
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Apr 2016
- Phase
- Observational
- 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
Study population: Patients presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
Who may be able to join
- Male or female subjects over the age of 18
- Presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
- Willing and able to comply with study procedures
- Able to provide written informed consent
Who cannot join
- Unwilling or unable to provide written informed consent and to comply with study procedures;
- Unwilling or unable to provide buccal swab sample
- History of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5);
- New York Heart Classification >3
- Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis);
- History of malabsorption (short gut syndrome);
- Gastric or small bowel surgery less than 3 months prior to study enrollment;
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures Compared to Historical Data
The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process for patients undergoing bowel surgery, major urologic procedure, or major ventral hernia repair and requiring post-operative acute pain management in an inpatient basis, as compared to a group of subjects with the same attributes without the guidance of PGx testing (historical control group). This study will also evaluate the frequency with which the standard analgesic care plan is adjusted by test results.
Read the detailed description
The incidence of opioid-related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26D alleles. There is a growing body of literature that indicate that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.
Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.
In this prospective, observational, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on patient well-being as determined by post-op pain assessments and the frequency of changes in analgesics predicted by testing results. Additionally, the impact of PGx-guided treatment on narcotic consumption, time to mobilization, number of adverse events, length of stay, and re-admission rates compared to historical data will be evaluated during the duration of the study.
- Conditions
- Acute Pain, Surgery
- Being tested
- NeuroIDgenetix Test Panel
- Keywords
- PGx, pharmacogenetic testing, Pain Management, AltheaDx, Post-Operative Pain Management
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroIDgenetix Test PanelOther
Also called IDgenetix Neuro Test, PGx Testing
The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.
| Study group | Role | What they receive |
|---|---|---|
| NeuroIDgenetix-guided Pain Management | The medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, narcotic consumption, opioid-related adverse effects, time to mobilization, number of adverse drug events and number of hospital and/or medical visits will be measured throughout the study. Receives: Other: NeuroIDgenetix Test Panel | |
| Historical Control | The retrospective chart review will utilize patient outcomes from patients meeting the study inclusion/exclusion criteria. The medical provider for the control group will not have received the NeuroIDgenetix Test Panel results and would have made post-operative pain management recommendations per standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patient well-being measured by OBAS score between the two study groups.
Comparison of patient well-being between experimental and control group as measured by Overall Benefit of Analgesics (OBAS) score.
Measured: From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Comparison of length of post-surgical hospital stay between the two study groups
Comparison of duration of post-surgical hospital stay between experimental and control group.
Measured: From date of surgery until hospital discharge, assessed up to 1 month
Comparison of patient well-being measured by BPI score between the two study groups
Comparison of patient well-being between experimental and control group as measured by Brief Pain Inventory-Short Form score.
Measured: From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Secondary outcomes (2)
Comparison of post-operative narcotic consumption between the two study groups
Comparison of post-operative narcotic consumption between the two study groups
Measured: From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Comparison of time to mobilization between the two study groups
Comparison of time to mobilization between the two study groups
Measured: From date of surgery to mobilization, assessed up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- AltheaDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Sponsor
- Investigators
- Anthony J Senagore, MD, Principal investigator, University Hospitals Case Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605343
- Sponsor's protocol ID
- CLP0006
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2015
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures Compared to Historical Data
- ClinicalTrials.gov ID
- NCT02605343
- Acronym / sponsor ID
- CLP0006
- Conditions
- Acute Pain, Surgery
- Keywords
- PGx, pharmacogenetic testing, Pain Management, AltheaDx, Post-Operative Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AltheaDxIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Nov 2015 (estimated)
- 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 purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process for patients undergoing bowel surgery, major urologic procedure, or major ventral hernia repair and requiring post-operative acute pain management in an inpatient basis, as compared to a group of subjects with the same attributes without the guidance of PGx testing (historical control group). This study will also evaluate the frequency with which the standard analgesic care plan is adjusted by test results.
Detailed description
The incidence of opioid-related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26D alleles. There is a growing body of literature that indicate that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.
Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.
In this prospective, observational, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on patient well-being as determined by post-op pain assessments and the frequency of changes in analgesics predicted by testing results. Additionally, the impact of PGx-guided treatment on narcotic consumption, time to mobilization, number of adverse events, length of stay, and re-admission rates compared to historical data will be evaluated during the duration of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroIDgenetix-guided Pain Management | – | Other: NeuroIDgenetix Test PanelThe medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, narcotic consumption, opioid-related adverse effects, time to mobilization, number of adverse drug events and number of hospital and/or medical visits will be measured throughout the study. |
| Historical Control | – | –The retrospective chart review will utilize patient outcomes from patients meeting the study inclusion/exclusion criteria. The medical provider for the control group will not have received the NeuroIDgenetix Test Panel results and would have made post-operative pain management recommendations per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
Key inclusion criteria (4 listed)
- Male or female subjects over the age of 18
- Presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
- Willing and able to comply with study procedures
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Unwilling or unable to provide written informed consent and to comply with study procedures;
- Unwilling or unable to provide buccal swab sample
- History of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5);
- New York Heart Classification >3
- Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis);
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 |
|---|---|---|
| NeuroIDgenetix Test PanelAlso: IDgenetix Neuro Test, PGx TestingThe NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient. | Other | NeuroIDgenetix-guided Pain Management |
Primary outcome
Comparison of patient well-being measured by OBAS score between the two study groups.
Time frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Comparison of patient well-being between experimental and control group as measured by Overall Benefit of Analgesics (OBAS) score.
Comparison of length of post-surgical hospital stay between the two study groups
Time frame: From date of surgery until hospital discharge, assessed up to 1 month
Comparison of duration of post-surgical hospital stay between experimental and control group.
Comparison of patient well-being measured by BPI score between the two study groups
Time frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Comparison of patient well-being between experimental and control group as measured by Brief Pain Inventory-Short Form score.
2 secondary outcomes
Comparison of post-operative narcotic consumption between the two study groups
Time frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery
Comparison of time to mobilization between the two study groups
Time frame: From date of surgery to mobilization, assessed up to 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- 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.
Anthony J Senagore, MD principal investigator
University Hospitals Case Medical Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Surgery, run by AltheaDx 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 6 Jun 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of patient well-being measured by OBAS score between the two study groups. (time frame: From date of surgery until last follow-up visit, assessed at 30 days post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2016.