Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures

Surgery Clinical Trial

Official title:

Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures Compared to Historical Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605343
• Other study ID #: CLP0006
• Status: Completed
• Phase: N/A
• First received: November 6, 2015
• Last updated: June 2, 2016
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: AltheaDx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pain
• Surgery

Intervention

Other:
• NeuroIDgenetix Test Panel
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.

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
AltheaDx	University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of surgery until last follow-up visit, assessed at 30 days post-surgery	No
Primary	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.	From date of surgery until hospital discharge, assessed up to 1 month	No
Primary	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.	From date of surgery until last follow-up visit, assessed at 30 days post-surgery	No
Secondary	Comparison of post-operative narcotic consumption between the two study groups	Comparison of post-operative narcotic consumption between the two study groups	From date of surgery until last follow-up visit, assessed at 30 days post-surgery	No
Secondary	Comparison of time to mobilization between the two study groups	Comparison of time to mobilization between the two study groups	From date of surgery to mobilization, assessed up to 30 days post-surgery	No

External Links

•   IDgenetix gives you the power to offer personalized medicine to your patients through a combination of comprehensive pharmacogenetic testing and a proprietary algorithmic screening process.