Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06065566
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2020-01-10
Brief Title:
Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Instituto Mexicano del Seguro Social
Study Overview
Official Title:
Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers in Patients Undergoing to Cardiac Surgery With and Without Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 04 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 04 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 Students 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 005 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 200 SPSS Chicago ILL USA
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
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 04 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 Students 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 005 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 200 SPSS Chicago ILL USA
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None