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临床试验/NCT06065566
NCT06065566已完成不适用

Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers in Patients Undergoing to Cardiac Surgery With and Without Cardiopulmonary Bypass

Instituto Mexicano del Seguro Social2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Troponin I

研究概览

简要总结

The effect of parenteral glutamine on the biomarkers of myocardial injury and inflammation in patients undergoing cardiac surgery with and without cardiopulmonary bypass (DCP) will be analyzed. Randomized controlled clinical trial, from October 2018 to February 2022. 124 patients: 14 patients with DCP and 14 patients without DCP, both + glutamine (L-alanyl-L-glutamine dipeptide, at a dose of 0.4 g / kg) 6 hours before surgery and 14 patients with PCD and 14 patients without PCD + placebo (saline) 6 hours before surgery. Blood samples will be taken to measure the level of TROP-I, CPK-MB, HSP-70, TNFa, IL6, IL10 and PCR 1 hour before the administration of Glutamine / Placebo, 1 hour before surgery, then at 1 , 12 and 24 hours after surgery.

详细描述

Introduction: Cardiac surgery is performed in order to improve function and decrease the incidence of cardiac events. The provision of different metabolic substrates before and during cardiac surgery can have beneficial effects, limiting the damage caused by ischemia / reperfusion (I / R) induced by this type of surgery with and without cardiopulmonary bypass, reflected in a better recovery and survive. Glutamine (GLN) is a non-essential amino acid should be a primary part of medical and nutritional therapy in severe patients, since the reduction of this is associated in various critical conditions including multiple trauma, sepsis or after major surgery. In cardiac patients, the concentration of intracellular GLN is always reduced regardless of the surgical technique used.

Objective: To analyze the effect of parenteral glutamine in the biomarkers of myocardial injury and inflammation in patients undergoing cardiac surgery with and without cardiopulmonary bypass.

Hypothesis: Supplementation with parenteral glutamine reduces the expression of biomarkers of myocardial injury and inflammation in patients undergoing cardiac surgery with and without cardiopulmonary bypass.

Material and methods: A randomized controlled clinical trial will be carried out according to the consort 2010 criteria, in a period from October 2018 to September 2020. A total of 124 patients will be included that will be randomized as follows: 14 patients with referral cardiopulmonary + Glutamine and 14 patients without cardiopulmonary bypass + Glutamine who will receive the dipeptide L-alanyl-L-glutamine, at a dose of 0.4 g / kg of weight 6 hours before surgery and 14 patients with cardiopulmonary bypass and 14 patients without bypass cardiopulmonary, who will receive placebo in the form of saline solution in a volume similar to the control 6 hours before the surgical intervention. Blood samples will be taken to measure the level of TROP-I, CPK-MB, HSP-70, TNFα, IL6, IL10 and PCR 1 hour before the administration of Glutamine / Placebo, 1 hour before surgery, then 1 hour after of surgery and at 12 and 24 hours after surgery to be taken to the laboratory of the Post-surgical Coronary Care Unit and obtain the reading of the samples.

Statistical analysis: Averages and standard deviations for quantitative variables will be calculated; frequencies and proportions in qualitative variables. For statistical inference. Quantitative variables will be analyzed with Student's t-test for independent samples. ANOVA will be used for repeated measurements in each group to obtain the difference of the final value minus the initial one in the dependent variable (δ). Considering two-tailed tests, any value of p <0.05 will be considered statistically significant. The data will be captured in an Excel file and the statistical analysis will be carried out with the statistical package SPSS version 20.0, (SPSS, Chicago, ILL, U.S.A.).

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
Single (Care Provider)

盲法说明

A third person, the cardiothoracic surgery floor nurse, will assign the patients to the study group or control group by means of a sealed envelope. Registration will be carried out by this single person until the final results are revealed.

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of ischemic heart disease who will undergo surgery to CRC.
  • Age 40 to 70 years.
  • BMI from 18.5 to 29.9 kg / m2
  • Stable renal function with a serum creatinine less than 1.5 mg / dl.
  • Complete and signed informed consent.

排除标准

  • Left ventricular ejection fraction <40%.
  • Pre-existing disease such as: Renal impairment under substitute treatment (peritoneal dialysis or hemodialysis), Hepatic impairment, Human immunodeficiency syndrome, Viral liver disease (due to virus B and C).
  • Patients with previous cardiac surgery.
  • Emergency surgery or myocardial ischemia in progress.
  • Known allergy to the supplement to be used in the study
  • Alcohol abuse or drug use 1 month before surgery

结局指标

主要结局

Troponin I

时间窗: 24 hours

Kit de Troponin-I ELISA, Biometrica, California, USA Evaluado a través de un analizador automático (ELx808 Absorbance Lector de microplacas; BioTek, Winooski, VT, EE. UU

IL-6 IL-10 FNTα

时间窗: 24 hours

ELISA (KMI Diagnostics, Minneapolis, MN and Flanders, NJ). The results were obtained by spectrophotometry (Thermo Opsys MR Laboratory Systems, Chantily, VA).

CPK y CPK MB

时间窗: 24 hours

Analyzed with Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD)

Heat shock proteins 70 (HSP 70)

时间窗: 24 hours

Measurement in mononuclear cells in peripheral blood. Analyzed with Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD)

次要结局

未报告次要终点

研究者

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

GONZALEZ-OJEDA ALEJANDRO

Principal Investigator

Instituto Mexicano del Seguro Social

研究点 (2)

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