Retrospective Analysis of Clinical Outcomes Associated With Use of the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients Within the Cerner HealthFacts Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,844
- 主要终点
- Hospital mortality during index visit
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoes a qualifying cardiac surgery between Jan 1, 2010 and January 1,
- •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
排除标准
- •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
结局指标
主要结局
Hospital mortality during index visit
时间窗: Admission through up to 180 days (hospital discharge)
Major Adverse Cardiac Events (MACE)
时间窗: Through 90 days
Hospital length-of-stay (LOS)
时间窗: Admission through up to 180 days (hospital discharge)
Index hospital visit LOS
Hospital readmission
时间窗: Through 90 days
Rate of hospital readmissions
Major morbidity composite
时间窗: Through 90 days
次要结局
- New organ failure (cardiovascular, respiratory, coagulation, liver systems, renal)(Day 1 to discharge (up to 180 days))
- Requirement for mechanical ventilation(Day 1 to discharge (up to 180 days))
- Acute kidney injury (KDIGO staging)(Day 1 to day 10)
- Gastrointestinal complication (hepatic)(Day 1 to discharge (up to 180 days))
- Respiratory failure(Day 1 to discharge (up to 180 days))
- Sequential Organ Failure Assessment (SOFA) scores(Day 1 to discharge (up to 180 days))
- Neurologic complication(Day 1 to discharge (up to 180 days))
- Hemorrhage requiring blood transfusion(Day 1 to discharge (up to 180 days))
- Infectious complications(Day 1 to discharge (up to 180 days))
研究者
Andrew Shaw
Professor and Executive Vice Chair Department of Anesthesiology Executive Medical Director, Perioperative Services
Vanderbilt University