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临床试验/NCT04606264
NCT04606264已完成3 期

Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP)

Jennifer Holder-Murray6 个研究点 分布在 1 个国家目标入组 3,395 人开始时间: 2023年5月15日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
3,395
试验地点
6
主要终点
30 day hospital free days

研究概览

简要总结

This REMAP Periop ERP domain study falls under the Periop Core Protocol, which compares the different recommended strategies for enhancing recovery through the use of various standard of care treatments before, during and after surgery in all patients with elective surgical encounters at UPMC who meet eligibility criteria.

The ERP domain seeks to enhance recovery by optimizing strategies of perioperative care through evaluating combinations of perioperative treatment, which consists of preoperative, intraoperative and postoperative care. Optimal combinations of perioperative care will be generated and analyzed to determine the best outcomes for patients as defined by reduction in hospital free days, reduction in postoperative nausea and vomiting, and improved pain control.

详细描述

The Periop Core Protocol is an administration structure designed to provide appropriate management of all aspects of the study, taking into account multiple factors including representation from clinics and hospitals that are participating in the trial, availability of skills and expertise related to trial conduct and statistical analysis, and content knowledge regarding acute illness, elective surgery, and the interventions that are being evaluated. Eligible patients will be randomized to a recommended set of standard of care treatments related to their surgery to identify those that improve outcomes as defined by hospital free days at 30 days from the date of the surgical encounter. The administration model is designed to provide effective operational and strategic management of the REMAP that operates in multiple UPMC facilities, is supported by multiple funding bodies and sponsors, and will evolve with addition of domains and interventions that are being evaluated.

The ERP domain under the Periop Core Protocol will evaluate the varying recommended combinations of perioperative treatments, in hopes to determine the optimal strategies for perioperative care based on surgery type and patient specific factors. In this study, patient care components within the preoperative, perioperative, and postoperative domains will be randomized with a machine learning REMAP technique. Optimal strategies combining the entire perioperative process will be analyzed that determine best outcomes for patients including hospital free days, reductions in postoperative nausea and vomiting, and improved pain control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is seen in preoperative appointment prior to surgery
  • ≥ 18 years of age
  • Anticipated overnight hospital stay
  • Scheduled for elective abdominal surgery that utilizes ERP PowerPlans - placed into the patient's electronic chart at least one night before surgery
  • ERP Abdominal Complex Pathway PowerPlan (used for colorectal and gastrointestinal surgery)
  • ERP Bariatric Surgery Pathway PowerPlan
  • ERP Gynecology Oncology Pathway PowerPlan
  • ERP Whipple/Pancreas Pathway PowerPlan
  • ERP Open Liver Resection Pathway PowerPlan
  • Surgery is scheduled for one of the following UPMC sites:
  • UPMC Presbyterian Hospital
  • UPMC Passavant Hospital
  • UPMC Magee-Women's Hospital
  • Exclusion Critera
  • Death is deemed to be imminent or inevitable
  • Patient is pregnant < 18 years of age
  • Patients undergoing emergent/urgent surgery
  • Patients that are pregnant
  • Patients that have an eligible PowerPlan ordered less than one night before surgery

排除标准

  • 未提供

结局指标

主要结局

30 day hospital free days

时间窗: Day 0 - Day 30

The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter.

次要结局

  • Change in the rate of postoperative opioid use by measurement of oral morphine equivalents (OME) postoperative day 0 to postoperative day 1(Day 0 - Day 1)
  • Change in postoperative nausea and vomiting (PONV) by measurement incidences of emesis within 24 hours post surgery(0 - 24 hours surgery)

研究者

发起方
Jennifer Holder-Murray
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jennifer Holder-Murray

Assistant Professor

University of Pittsburgh

研究点 (6)

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