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Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers

NCT06065566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Insufficiency;Cardiac

Interventions

DIETARY_SUPPLEMENT

L-alanyl-L-glutamine dipeptide

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2021-02-04
Completion
2022-02-04

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065566 on ClinicalTrials.gov