Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 6:42 PM
Study NCT ID:
NCT06065566
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2020-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.\n\nA. 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.\n\nB. 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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2020-01-10', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Troponin I', 'timeFrame': '24 hours', 'description': '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'}, {'measure': 'Heat shock proteins 70 (HSP 70)', 'timeFrame': '24 hours', 'description': 'Measurement in mononuclear cells in peripheral blood. Analyzed with Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD)'}, {'measure': 'IL-6 IL-10 FNTα', 'timeFrame': '24 hours', 'description': 'ELISA (KMI Diagnostics, Minneapolis, MN and Flanders, NJ). The results were obtained by spectrophotometry (Thermo Opsys MR Laboratory Systems, Chantily, VA).'}, {'measure': 'CPK y CPK MB', 'timeFrame': '24 hours', 'description': 'Analyzed with Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular surgery', 'Glutamine', 'Heart damage markers'], 'conditions': ['Insufficiency;Cardiac']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nObjective: 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.\n\nHypothesis: Supplementation with parenteral glutamine reduces the expression of biomarkers of myocardial injury and inflammation in patients undergoing cardiac surgery with and without cardiopulmonary bypass.\n\nMaterial 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.\n\nStatistical 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.).\n\nEthical 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).\n\nStudy time: It will take place from October 2018 to June 2021."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of ischemic heart disease who will undergo surgery to CRC.\n* Age 40 to 70 years.\n* BMI from 18.5 to 29.9 kg / m2\n* Stable renal function with a serum creatinine less than 1.5 mg / dl.\n* Complete and signed informed consent.\n\nExclusion Criteria:\n\n* Left ventricular ejection fraction \\<40%.\n* 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).\n* Patients with previous cardiac surgery.\n* Emergency surgery or myocardial ischemia in progress.\n* Known allergy to the supplement to be used in the study\n* Alcohol abuse or drug use 1 month before surgery'}, 'identificationModule': {'nctId': 'NCT06065566', 'briefTitle': 'Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers in Patients Undergoing to Cardiac Surgery With and Without Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'R-2019-1001-079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients on bypass with cardiopulmonary bypass +gluta', 'description': 'Patients operated on bypass with cardiopulmonary bypass + glutamine', 'interventionNames': ['Dietary Supplement: L-alanyl-L-glutamine dipeptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients on bypass + cardiopulmonary bypass + glutamine', 'description': 'Patients operated on bypass with cardiopulmonary bypass + glutamine', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'patients without bypass + cardiopulmonary bypass +glutamine', 'description': 'Patients operated without bypass with cardiopulmonary bypass + glutamine', 'interventionNames': ['Dietary Supplement: L-alanyl-L-glutamine dipeptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients without bypass + cardiopulmonary bypass +placebo', 'description': 'Patients operated without bypass with cardiopulmonary bypass + placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'L-alanyl-L-glutamine dipeptide', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Glutamine'], '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.\n\nA. 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.", 'armGroupLabels': ['Patients on bypass with cardiopulmonary bypass +gluta', 'patients without bypass + cardiopulmonary bypass +glutamine']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Saline solution'], '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.\n\nB. 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.", 'armGroupLabels': ['Patients on bypass + cardiopulmonary bypass + glutamine', 'Patients without bypass + cardiopulmonary bypass +placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44329', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto Mexicano del Seguro Social', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'GONZALEZ-OJEDA ALEJANDRO', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}