跳至主要内容
临床试验/NCT04665583
NCT04665583终止不适用

Single-Center, Prospective, Open-Label Study Standardizing a Prehabilitation Protocol to Optimize Patients Prior to Undergoing Tricuspid Intervention

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
1
主要终点
Change in volume status according to daily input/outputs

研究概览

简要总结

This study will aim to standardize the prehabilitation protocol to optimize patients and document the clinical and echo variables that could improve clinical outcomes of tricuspid valve intervention.

详细描述

Prior to screening activities, each subject will be given an opportunity to ask questions and to understand the details of study participation. Subjects who meet the inclusion and exclusion criteria and have signed an informed consent form will be considered enrolled into the study. After a subject is consented and enrolled in the study, data will be collected prior to any intervention or surgery at the following time points: a) Screening/Baseline b) Day 1 of Prehab c) Day 2 of Prehab d) Day 3 of Prehab e) Day 4 of Prehab, f) and any data collected immediately prior to an intervention or incision (in the case of a surgical patient)

Subjects meeting eligibility criteria with planned tricuspid intervention will receive in-hospital optimization with THHBP's Prehab Protocol.

Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care. If there are clinical and functional signs of improvement before Day 4, and the subject is ready for TV surgery or any other intervention, they will have Day 4 procedures performed. After the tests and evaluations are completed, the Principal Investigator or Sub-Investigators will decide if the patient is a candidate for TV surgery or another intervention

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • ≥ 18 years of age
  • Moderate-Severe or Severe TR
  • Undergoing tricuspid valve surgical or catheter-based intervention

排除标准

  • Clinical instability according to the judgement of the Investigator

结局指标

主要结局

Change in volume status according to daily input/outputs

时间窗: 4-5 days (Day 1 to Day 4 of Prehab or day of surgical intervention)

daily input/outputs (mL)

Change in volume status according to weight

时间窗: 5-6 days (Baseline to Day 4 of Prehab or day of surgical intervention)

daily weights (kg)

Change in Severity of Tricuspid Regurgitation by Echocardiographic assessment

时间窗: 5 days (Baseline to Day 4 of Prehab)

severity of tricuspid regurgitation (mild, moderate, severe)

Change in Nutritional Status

时间窗: 4 days (Baseline to Day 3 of Prehab)

Pre-albumin (mg/dL)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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