Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers
Condition: Insufficiency;Cardiac
MeSH terms: Heart Failure; Inflammation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.).

      Ethical considerations: This study will adhere to the principles emanating from the 18th
      medical assembly of Helsinki, Finland in 1964 and the modifications made by that assembly in
      Tokyo, Japan in 1975, in Venice, Italy in 1983, in Hong Kong in 1989 and the 54th General
      Assembly in Seoul Korea in 2008, where medical research is contemplated (Clinical Research).
      It will also be in accordance with what is specified by the General Health Law of Mexico, in
      the area of health research, in its article 17, considering the present study with a risk
      greater than the minimum. Likewise, the institutional norm of the IMSS for research of human
      beings will be followed. All participants will sign their written consent. Resources:
      Patients treated at the UMAE Hospital de Especialidades del CMNO. The protocol was approved
      with registration number R 2018 1001 079. Group Experience: The Advisor has the experience
      and scientific knowledge of the realization and publication of research studies (Level II and
      Level III of the SNI).

      Study time: It will take place from October 2018 to June 2021.
    

Intervention name(s): L-alanyl-L-glutamine dipeptide; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1. Once the candidate patients undergo surgery for cardiac surgery with and without cardiopulmonary bypass, the inclusion criteria will be verified. Once their inclusion in the study has been accepted, the patient must sign their informed consent letter and will be randomly assigned by closed envelope, to a study group or to a control group. The patient's weight and height will be taken once he accepts inclusion in the study and the data collection notebook will be filled.
A. Study group: patients undergoing cardiac surgery with and without cardiopulmonary bypass, who will receive the dipeptide L-alanyl-L-glutamine, at a dose of 0.4 g / kg of weight 6 hours before the surgical intervention.; 1. Once the candidate patients undergo surgery for cardiac surgery with and without cardiopulmonary bypass, the inclusion criteria will be verified. Once their inclusion in the study has been accepted, the patient must sign their informed consent letter and will be randomly assigned by closed envelope, to a study group or to a control group. The patient's weight and height will be taken once he accepts inclusion in the study and the data collection notebook will be filled.
B. Control group: patients undergoing cardiac surgery with and without cardiopulmonary bypass, who will receive the placebo in the form of saline solution in a volume similar to the control 6 hours before the surgical intervention.
Other intervention name(s): Glutamine; Saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1. Once the candidate patients undergo surgery for cardiac surgery with and without cardiopulmonary bypass, the inclusion criteria will be verified. Once their inclusion in the study has been accepted, the patient must sign their informed consent letter and will be randomly assigned by closed envelope, to a study group or to a control group. The patient's weight and height will be taken once he accepts inclusion in the study and the data collection notebook will be filled.
A. Study group: patients undergoing cardiac surgery with and without cardiopulmonary bypass, who will receive the dipeptide L-alanyl-L-glutamine, at a dose of 0.4 g / kg of weight 6 hours before the surgical intervention.
B. Control group: patients undergoing cardiac surgery with and without cardiopulmonary bypass, who will receive the placebo in the form of saline solution in a volume similar to the control 6 hours before the surgical intervention.
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Cardiovascular surgery; Glutamine; Heart damage markers