Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
2017年2月15日 更新者：Andrew Shaw、Vanderbilt University
Retrospective Analysis of Clinical Outcomes Associated With Use of the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients Within the Cerner HealthFacts Database
The primary objective for this retrospective Electronic Health Record (EHR) analysis is to evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants).
The study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan.
1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO).
研究概览
详细说明
A retrospective study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan.
1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO).
Patients who underwent a qualifying cardiac surgery (verified through use of selected valid International Classification of Diseases-9 procedure codes and/or Current Procedural Terminology [CPT] codes) will be included.
Each patient's cohort designation will be defined based upon whether he/she did or did not receive a pulmonary artery catheter (PAC) for monitoring purposes.
Propensity scores, which take into account patient and hospital demographics, patient comorbidities, surgical type (isolated coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants), and pre-operative condition (via an adapted EuroSCORE II) will be utilized to "match" patients who received a PAC for monitoring purposes with those who did not, to form a matched study cohort.
Clinical outcomes will be monitored through index visit discharge and up to 90 days post index visit discharge.
研究类型
观察性的
注册 (实际的)
6844
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Adult patients undergoing an isolated CABG, isolated valve, aortic procedure, complex nonvalvular procedures, multi-procedures or a heart transplant who receives or does not receive a pulmonary artery catheter (PAC) for monitoring purposes
描述
Inclusion Criteria:
- Patient undergoes a qualifying cardiac surgery between Jan 1, 2010 and January 1, 2015. If multiple qualifying surgeries are present, the first in database will be utilized
- Inpatient with a LOS of at least 48 hours
- Treated arm receives a PAC for monitoring purposes within admission date and qualifying cardiac surgical day plus one via specified ICD-9 or CPT-4 codes, or EHR recorded PAC readings
Exclusion Criteria:
- Cardiac surgery patients with age <18 years on index procedure date
- Non-treated arm derived from an institution which does not have database documented use of ICD-9 or CPT-4 PAC placement codes for monitoring purposes [Lessens the likelihood that the untreated arm is indeed treated by ensuring that the patient would likely be coded if he/she had a PAC in place for monitoring purposes]
- Patient record must have the demographics populated of age, gender, and race. ICD-9 diagnosis and procedure codes must be present in record for index visit, as well as medications administered over index visit
- Patient must be treated at a hospital which performs a minimum of 100 qualifying cardiac procedures per year
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Pulmonary artery catheter (PAC)
Patients received a PAC for monitoring purposes
|
PAC must be placed between the day of admission and the day following a qualifying cardiac surgery
其他名称：
|
|
No pulmonary artery catheter (PAC)
Patients did not receive a PAC for monitoring purposes
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hospital mortality during index visit
大体时间：Admission through up to 180 days (hospital discharge)
|
Admission through up to 180 days (hospital discharge)
|
|
|
Hospital length-of-stay (LOS)
大体时间：Admission through up to 180 days (hospital discharge)
|
Index hospital visit LOS
|
Admission through up to 180 days (hospital discharge)
|
|
Hospital readmission
大体时间：Through 30 days
|
Rate of hospital readmissions
|
Through 30 days
|
|
Hospital readmission
大体时间：Through 60 days
|
Rate of hospital readmissions
|
Through 60 days
|
|
Hospital readmission
大体时间：Through 90 days
|
Rate of hospital readmissions
|
Through 90 days
|
|
Major Adverse Cardiac Events (MACE)
大体时间：Through 30 days
|
Through 30 days
|
|
|
Major Adverse Cardiac Events (MACE)
大体时间：Through 60 days
|
Through 60 days
|
|
|
Major Adverse Cardiac Events (MACE)
大体时间：Through 90 days
|
Through 90 days
|
|
|
Major morbidity composite
大体时间：Through 30 days
|
Through 30 days
|
|
|
Major morbidity composite
大体时间：Through 60 days
|
Through 60 days
|
|
|
Major morbidity composite
大体时间：Through 90 days
|
Through 90 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Requirement for mechanical ventilation
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Hemorrhage requiring blood transfusion
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Acute kidney injury (KDIGO staging)
大体时间：Day 1 to day 10
|
Day 1 to day 10
|
|
Infectious complications
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Gastrointestinal complication (hepatic)
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Respiratory failure
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Sequential Organ Failure Assessment (SOFA) scores
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
|
Neurologic complication
大体时间：Day 1 to discharge (up to 180 days)
|
Day 1 to discharge (up to 180 days)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Andrew D Shaw, MB, FRCA, FFICM, FCCM、Vanderbilt University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (实际的)
2016年11月1日
研究完成 (实际的)
2016年11月1日
研究注册日期
首次提交
2016年10月18日
首先提交符合 QC 标准的
2016年11月10日
首次发布 (估计)
2016年11月15日
研究记录更新
最后更新发布 (实际的)
2017年2月17日
上次提交的符合 QC 标准的更新
2017年2月15日
最后验证
2017年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.