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临床试验/NCT03445221
NCT03445221已完成2 期

Implication of Preoperative Immunonutrition Upon Cardiac Patients Undergoing Mitral Valve Replacement Surgery

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed F. Mostafa

Associate Professor of Anesthesia and Intensive Care

Assiut University

研究点 (2)

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