Implication of Preoperative Immunonutrition Upon Cardiac Patients Undergoing Mitral Valve Replacement Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cardiac Fuction
研究概览
简要总结
With the progress of cardiac surgery, the indication of cardiac valve replacement has been extended to include severely ill patients, even those with cardiac cachexia caused by long-standing mitral valve disease. Since patients with advanced cardiac functional disability are prone to fall into a low cardiac output state after valve replacement, Those severely ill, cachectic patients may be susceptible to postoperative acute renal failure. Preoperative malnutrition because of poor oral intake significantly increases the risk of adverse events after surgery and leads to increased length of stay.
Major operation itself possibly cause the dysfunction of the host homeostasis, defense mechanisms and inflammatory response, which would increase the rate of postoperative complications and prolong hospital stay. Recently, many researchers argued that immunonutritional formulas supplemented with biologically active nutrients were more effective than standard nutrition intervention in improving inflammation, promoting the wound healing and shortening the length of hospital stay (LOS) after operation.
详细描述
Eligibility and type of the study: This randomized clinical trial will be conducted at Assiut University Hospital from March 2018 until March 2019 after approval from the Institutional Ethics Committee and after obtaining written informed consents from all cardiac patients undergoing mitral valve replacement surgery.
Randomization and sample size :
Sample size calculation Sample size calculation was carried out using G*Power 3 software. A calculated sample of 88 patients (44 cases and 44 controls) will be needed to detect an effect size of 0.3 reduction in pro-BNP Level, with an error probability of 0.05 and 90% power on a two-tailed test.
Patients:
Patients will be assigned into two equal groups of 44 patients each:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years.
- •Valvular heart disease .
- •ASA II,III
- •Non-diabetic.
- •Elective surgery.
排除标准
- •Pre-existing renal disease(creatinine3.5mg/dl or dialysis)
- •Diabetic.
- •Off pump surgery.
- •Long CBP time >120 min .
- •Previous cardiac surgery.
- •Hepatic failure or established cirrhosis.
- •Emergency surgery
结局指标
主要结局
Cardiac Fuction
时间窗: 4 days
Serum proBNP (Brain natruritic peptide)
次要结局
- Hemodynamics(2 days)
- Kidney Function(4 days)
- Postoperative Hospital Data(4 days)
- Inotropic score(4 days)
- urine output(2 days)
- Postoperative complications(4 days)
研究者
Mohamed F. Mostafa
Associate Professor of Anesthesia and Intensive Care
Assiut University
