Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers

NCT06065566 | Completed

• 1 other identifier: R-2019-1001-079
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiovascular surgery; Glutamine; Heart damage markers

Outcome Measures

Primary Outcomes (4)

• Troponin I

  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

  24 hours

• Heat shock proteins 70 (HSP 70)

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

  24 hours

• IL-6 IL-10 FNTα

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

  24 hours

• CPK y CPK MB

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

  24 hours

Study Arms (4)

Patients on bypass with cardiopulmonary bypass +gluta

EXPERIMENTAL

Patients operated on bypass with cardiopulmonary bypass + glutamine

Dietary Supplement: L-alanyl-L-glutamine dipeptide

Patients on bypass + cardiopulmonary bypass + glutamine

PLACEBO COMPARATOR

Patients operated on bypass with cardiopulmonary bypass + glutamine

Other: Placebo

patients without bypass + cardiopulmonary bypass +glutamine

EXPERIMENTAL

Patients operated without bypass with cardiopulmonary bypass + glutamine

Dietary Supplement: L-alanyl-L-glutamine dipeptide

Patients without bypass + cardiopulmonary bypass +placebo

PLACEBO COMPARATOR

Patients operated without bypass with cardiopulmonary bypass + placebo

Other: Placebo

Interventions

L-alanyl-L-glutamine dipeptide DIETARY_SUPPLEMENT

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.

Also known as: Glutamine

Patients on bypass with cardiopulmonary bypass +gluta; patients without bypass + cardiopulmonary bypass +glutamine

Placebo OTHER

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.

Also known as: Saline solution

Patients on bypass + cardiopulmonary bypass + glutamine; Patients without bypass + cardiopulmonary bypass +placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Instituto Mexicano del Seguro Social

Guadalajara, Jalisco, 44329, Mexico

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Glutamine; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: October 4, 2023
• Study Start: February 4, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)