Insufficiency;CardiacNCT06065566
Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers
A study testing L-alanyl-L-glutamine dipeptide in people with Insufficiency;Cardiac, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Insufficiency;Cardiac
- What is being tested?
- L-alanyl-L-glutamine dipeptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteMexico
- Study dates
- 4 Feb 2020to 4 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers in Patients Undergoing to Cardiac Surgery With and Without Cardiopulmonary Bypass
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.
Read the 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.
- Conditions
- Insufficiency;Cardiac
- Being tested
- L-alanyl-L-glutamine dipeptide, Placebo
- Keywords
- Cardiovascular surgery, Glutamine, Heart damage markers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-alanyl-L-glutamine dipeptideDietary supplement
Also called Glutamine
- 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.
- 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.
PlaceboOther
Also called Saline solution
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Patients on bypass with cardiopulmonary bypass +gluta | Experimental | Patients operated on bypass with cardiopulmonary bypass + glutamine Receives: Dietary Supplement: L-alanyl-L-glutamine dipeptide |
| Patients on bypass + cardiopulmonary bypass + glutamine | Placebo comparator | Patients operated on bypass with cardiopulmonary bypass + glutamine Receives: Other: Placebo |
| patients without bypass + cardiopulmonary bypass +glutamine | Experimental | Patients operated without bypass with cardiopulmonary bypass + glutamine Receives: Dietary Supplement: L-alanyl-L-glutamine dipeptide |
| Patients without bypass + cardiopulmonary bypass +placebo | Placebo comparator | Patients operated without bypass with cardiopulmonary bypass + placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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).
Measured: 24 hours
CPK y CPK MB
Analyzed with Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start4 Feb 2020
- Primary completion4 Feb 2021
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficiency;CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065566
- Sponsor's protocol ID
- R-2019-1001-079
- Status last verified
- Sep 2023
- First submitted
- 10 Jan 2020
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers in Patients Undergoing to Cardiac Surgery With and Without Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06065566
- Acronym / sponsor ID
- R-2019-1001-079
- Conditions
- Insufficiency;Cardiac
- Keywords
- Cardiovascular surgery, Glutamine, Heart damage markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients on bypass with cardiopulmonary bypass +gluta | Experimental | Dietary Supplement: L-alanyl-L-glutamine dipeptidePatients operated on bypass with cardiopulmonary bypass + glutamine |
| Patients on bypass + cardiopulmonary bypass + glutamine | Placebo comparator | Other: PlaceboPatients operated on bypass with cardiopulmonary bypass + glutamine |
| patients without bypass + cardiopulmonary bypass +glutamine | Experimental | Dietary Supplement: L-alanyl-L-glutamine dipeptidePatients operated without bypass with cardiopulmonary bypass + glutamine |
| Patients without bypass + cardiopulmonary bypass +placebo | Placebo comparator | Other: PlaceboPatients operated without bypass with cardiopulmonary bypass + placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-alanyl-L-glutamine dipeptideAlso: Glutamine1. 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. | Dietary supplement | Patients on bypass with cardiopulmonary bypass +gluta, patients without bypass + cardiopulmonary bypass +glutamine |
| PlaceboAlso: Saline solution1. 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 | Patients on bypass + cardiopulmonary bypass + glutamine, Patients without bypass + cardiopulmonary bypass +placebo |
Primary outcome
Troponin I
Time frame: 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
Heat shock proteins 70 (HSP 70)
Time frame: 24 hours
Measurement in mononuclear cells in peripheral blood. Analyzed with Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD)
IL-6 IL-10 FNTα
Time frame: 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
Time frame: 24 hours
Analyzed with Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-alanyl-L-glutamine dipeptide in people with Insufficiency;Cardiac, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin I (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.