Assessing gastrointestinal issues in patients after aortic surgery
Assessment of Gastrointestinal Dysfunction Through GIDS Scale and Intestinal Damage Biomarkers in Critically Ill Patients Undergoing Aortic Surgery and Its Association With Clinical Outcomes.
This study is testing how gut problems after aortic surgery affect recovery in critically ill patients on breathing machines to see if early detection can help improve their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cardiologia Ignacio Chavez Academic / other |
| Locations | 1 site (Mexico City, Tlalpan) |
| Trial ID | NCT06514170 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between gastrointestinal dysfunction and various clinical outcomes in critically ill patients who have undergone aortic surgery. Utilizing the Gastrointestinal Dysfunction Scale (GIDS) and biomarkers such as citrulline and intestinal fatty-acid binding protein (I-FABP), the study will monitor nutritional intake and complications in the intensive care unit (ICU). The goal is to identify gastrointestinal issues early to implement timely management strategies that could improve recovery and reduce mortality rates. The study focuses on patients requiring prolonged mechanical ventilation post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone surgical interventions on the aorta and require invasive mechanical ventilation for more than 48 hours.
Not a fit: Patients with pre-existing gastrointestinal issues or chronic intestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of gastrointestinal dysfunction, enhancing recovery and reducing mortality in patients after aortic surgery.
How similar studies have performed: While gastrointestinal dysfunction is a recognized issue in surgical patients, this specific approach using GIDS and biomarkers is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older. * Patients after surgical interventions (elective or urgency) on the aorta with cardiopulmonary bypass. * Invasive mechanical ventilation expected to be required more than 48 hours. * Signed informed consent. Exclusion Criteria: * Patients under mechanical ventilation with pre-existing gastrointestinal issues. * Diagnosis of adult congenital heart disease. * Ongoing pregnancy or lactation period. * Simultaneous participation in another clinical study involving experimental therapy. * Presence of chronic intestinal disease. * Previous gastrointestinal conditions detected during nutritional screening.
Where this trial is running
Mexico City, Tlalpan
- Instituto Nacional de Cardiología Ignacio Chávez — Mexico City, Tlalpan, Mexico (Recruiting)
Study contacts
- Principal investigator: Gustavo Rojas Velasco, MD — Head of the Cardiovascular Intensive Care Unit
- Study coordinator: Gustavo Rojas Velasco, MD
- Email: gustavorojas08@gmail.com
- Phone: +52 55 55732911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.