Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Tlalpan, 14080, Mexico
Location status: Recruiting
NCT Number: NCT06514170
The goal of this observational study is to determine the association of gastrointestinal dysfunction through the Gastrointestinal Dysfunction Scale (GIDS) tool and serum concentrations of citrulline and Intestinal fatty-acid binding protein (I-FABP) with primary [calories received, protein received, parenteral nutrition requirement and 28-day mortality in the intensive care unit (ICU)] and secondary (development of pneumonia, surgical and cardiovascular complications in the ICU, length of hospital and ICU stay, duration of mechanical ventilation) clinical outcomes in critically ill patients undergoing aortic surgery.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Mexico City, Tlalpan, 14080, Mexico
Location status: Recruiting
The treatment of choice for various cardiovascular diseases often involves cardiac surgery, including aortic surgery, which is performed to correct conditions related to this major vessel, such as aneurysms, stenosis, aortic dissections, as well as issues affecting the aortic valve. With the increasing prevalence of non-communicable chronic diseases, a 46% increase in demand for cardiac surgeries is projected by 2025. The post-surgical period, commonly in the intensive care unit (ICU), increases the risk of complications, especially in patients with pre-existing risk factors. In this regard, gastrointestinal (GI) dysfunction affects up to 63% of patients, being associated with complications and a mortality rate of 55% to 60%. Early detection of GI dysfunction allows for the implementation of management strategies. Additionally, the administration of appropriate nutritional therapy is essential for recovery, and GI dysfunction may limit nutrient absorption. Inadequate caloric intake has been linked to increased morbidity and mortality. Tools such as GIDS (Gastrointestinal Dysfunction Scale) and biomarkers like citrulline and I-FABP enable early evaluation of GI function, advancing monitoring and management. Identifying changes before serious complications arise allows for early and personalized interventions. Early detection not only prevents complications and improves quality of life but may also reduce mortality. This research project aims to address these gaps by early assessing GI dysfunction in post-aortic surgery patients. Utilizing the GIDS tool and biomarkers such as citrulline and I-FABP, the goal is to identify GI dysfunction early and its impact on nutrition administration.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
Time frame: Day 0 to day 7
Percentage representation of prescribed calories delivered daily via enteral and/or parenteral routes.
Time frame: Day 0 to day 7
Daily administration of protein (in grams) through enteral and/or parenteral routes.
Time frame: 7 days
Infections acquired in the hospital consist of ventilator-associated pneumonia, bloodstream infections, and infections related to urinary catheters
Time frame: 90 days
This outcome measures the percentage of patients who undergo one or more additional surgical operations related to the same condition after the initial surgery. The percentage is calculated by dividing the number of patients who require a repeat operation by the total number of patients who underwent the initial operation, multiplied by 100 to get the percentage.
Time frame: 90 days
Occurrences of patients being readmitted to the ICU from within the hospital.
Time frame: 90 days
Duration of time (days) in the ICU
Time frame: 90 days
Length of time (days) on mechanical ventilation (including still on mechanical ventilation at time of discharge)
Time frame: 90 days
Duration of time (days) in the hospital
Time frame: Day 0 to day 7
Parenteral nutrition requirement
Time frame: 28 days
Is the patient alive or deceased 28 days post admission.
Interested in participating?
Request InfoInstituto Nacional de Cardiologia Ignacio Chavez
Other
Assessment of Gastrointestinal Dysfunction Through GIDS Scale and Intestinal Damage Biomarkers in Critically Ill Patients Undergoing Aortic Surgery and Its Association With Clinical Outcomes.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04966247
Acute Aortic Syndrome, Aneurysm
London, United Kingdom
View Trial DetailsNCT07078383
Acute Aortic Syndrome, Aneurysm
Los Angeles, California, United States
View Trial DetailsNCT04149600
Aneurysm, Aortic Aneurysm
Boston, Massachusetts, United States
View Trial DetailsNCT07379294
AORTIC VALVE DISEASES, Acute Aortic Syndrome
View Trial Details