Clinical trial NCT04954365: Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment
Official title: PROMPT (PONV Rescue Outcomes After Amisulpride Treatment)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Nausea and Vomiting, Postoperative
Lead sponsor: Acacia Pharma Ltd
Sponsor class: INDUSTRY
Collaborators: name: ArborMetrix
First posted: 2021-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients (age ≥ 18 years) 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.

Brief summary: PROMPT (PONV Rescue Outcomes after AMisulPride Treatment) is an observational Phase IV study designed to evaluate real-world evidence in relation to the care continuum of Post Operative Nausea and Vomiting (PONV), as well as the effectiveness and safety of common pharmacologic rescue treatment regimens compared to IV amisulpride. There will be no predefined hypothesis regarding the magnitude of efficacy or safety of various treatment regimens from the cohorts observed. We are not proposing to directly recruit patients into this study.

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.).

Eligibility criteria: 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.

Primary outcomes:
measure: Time to PACU Discharge
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Acacia Pharma
name: Lynn Bichajian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.