- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954365
Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment (PROMPT)
PROMPT (PONV Rescue Outcomes After Amisulpride Treatment)
Study Overview
Status
Conditions
Detailed Description
Deidentified Electronic Health Record (EHR) information related to treatment of Post Operative Nausea and Vomiting (PONV) will be collected from academic and community hospitals throughout the United States. Deidentified EHRs for patients receiving treatment for PONV will be harvested in two cohorts:
Cohort 1, Rescue treatment according to the standard of care (SOC) at each study site prior to the introduction of IV amisulpride into clinical practice
Cohort 2, Rescue treatment IV amisulpride.
There is no planned investigational agent, prescribed treatment regimen, or mandated intervention, and treating clinicians will determine therapy for PONV according to clinical judgment. The projected inclusion over the course of this observational study is to enroll a total of 20,000+ patient EHRs evenly divided among those that received SOC and amisulpride treatment. Effectiveness and safety outcomes will be analyzed using standard statistical methods for observational studies. Comparison of deidentified patient EHRs in Cohort 1 and Cohort 2, including response rates, will be compiled and analyzed by an independent medical data analytics company.
In regard to a Quality Assurance (QA) Plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing, ArborMetrix performs QA as part of regular business. QA involves both automation testing and manual testing strategies including Failure Mode and Effects Analysis (FMEA), bounds testing and exploratory testing. Monitoring and auditing is done in line with their continued work toward HITRUST Compliance.
Regarding data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry, data validation is built into the registry configuration based on predefined rules as part of the data analytics and measures development. When receiving data in a batch, legal values, legal relationships, primary keys, constraints, duplicates, range, format, length, data type, parent-child relationship, variable name are all checked at both import and staging. The analytic process checks naming, ticket #, unit test (Statistical Analysis System (SAS), Structure Query Language (SQL)), integration, rules, range, consistency, outliers, missing and distribution. As part of the Risk and Reliability (RR) Adjustment, ArborMetrix checks missing, unique values, Observed to Expected (OE) ratio, C-stats, R squared and adjusted R squared. Report validation in the UI (User Interface), which in this case means the registry platform, compares reporting dictionary to analytic definition.
Regarding source data verification and assessing the accuracy, completeness, or representativeness of registry data, data for PROMPT is being pulled directly from the EMR system (i.e., external data sources) into the registry. No source data verification will be conducted.
Regarding Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management - there is no patient recruitment for PROMPT. It is an observational study. Information on data collection/management/analysis is answered in other questions. The change management system involves a Change Management Board, Change Management Request form outlining event spurring the change, requested date/time, engineers assigned, devices and/or systems being changed, a description of the change including technical details, impact, risk validation method and backout plan. The Request is peer reviewed and approved by leadership and technical personnel prior to implementation.
Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results - As part of the data integration process, if variables necessary to meet measure criteria are deemed not available, Acacia will determine the next steps (i.e., remove measure, change measure criteria, etc.).
Study Type
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adult patients (age ≥ 18 years)
- Patients having Post-Operative Nausea and Vomiting (PONV) during their Post-Anesthesia Care Unit (PACU) stay, regardless of type of surgery, anesthesia, pre-medication, comorbidities, etc.
Exclusion Criteria:
- Patients that do not meet the above inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort 1
Patients that received rescue treatment according to the standard of care (SOC).
|
Rescue Post-Operative Nausea and Vomiting (PONV) treatment
|
Cohort 2
Patients that received rescue treatment with IV amisulpride.
|
Rescue Post-Operative Nausea and Vomiting (PONV) treatment with Amisulpride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to PACU Discharge
Time Frame: 24 hours
|
Time in mins from administration of first PONV rescue medication to discharge from post-anaesthesia care unit
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn Bichajian, MD, Acacia Pharma
Publications and helpful links
General Publications
- Candiotti KA, Kranke P, Bergese SD, Melson TI, Motsch J, Siddiqui N, Chung F, Rodriguez Y, Minkowitz HS, Ayad SS, Diemunsch P, Fox G. Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Anesth Analg. 2019 Jun;128(6):1098-1105. doi: 10.1213/ANE.0000000000003733.
- Habib AS, Kranke P, Bergese SD, Chung F, Ayad S, Siddiqui N, Motsch J, Leiman DG, Melson TI, Diemunsch P, Fox GM, Candiotti KA. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial. Anesthesiology. 2019 Feb;130(2):203-212. doi: 10.1097/ALN.0000000000002509.
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Dopamine Agents
- Dopamine Antagonists
- Antidepressive Agents, Second-Generation
- Amisulpride
Other Study ID Numbers
- PROMPT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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