Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06065566 |
| Other study ID # |
R-2019-1001-079 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 4, 2020 |
| Est. completion date |
February 4, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Instituto Mexicano del Seguro Social |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
