NCT06514170 Gastrointestinal Dysfunction in Aortic Surgery Patients
| NCT ID | NCT06514170 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Cardiologia Ignacio Chavez |
| Condition | Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 114 participants |
| Start Date | 2024-07-23 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 114 participants in total. It began in 2024-07-23 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Gustavo Rojas Velasco, MD
PRINCIPAL INVESTIGATOR
Head of the Cardiovascular Intensive Care Unit
Frequently Asked Questions
Who can join the NCT06514170 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06514170 currently recruiting?
Yes, NCT06514170 is actively recruiting participants. Contact the research team at gustavorojas08@gmail.com for enrollment information.
Where is the NCT06514170 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06514170 clinical trial?
NCT06514170 is sponsored by Instituto Nacional de Cardiologia Ignacio Chavez. The principal investigator is Gustavo Rojas Velasco, MD at Head of the Cardiovascular Intensive Care Unit. The trial plans to enroll 114 participants.