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NCT Number: NCT06514170

Gastrointestinal Dysfunction in Aortic Surgery Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Tlalpan, 14080, Mexico

Location status: Recruiting

Location contact

Carla G Aguilar Rodríguez, MD

SUB_INVESTIGATOR

Daniel Manzur Sandoval, MD

SUB_INVESTIGATOR

Eduardo A Escudero González, MD

SUB_INVESTIGATOR

Gustavo Rojas Velasco, MD

CONTACT

[email protected]

+52 55 55732911 ext. 24507

Jacob J Cruz Sánchez, MSc

CONTACT

[email protected]

+52 5512439841

Jacob J Cruz Sánchez, MSc

SUB_INVESTIGATOR

María L Tovar Hernández, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Calories delivered daily enterally and/or parenterally

    Time frame: Day 0 to day 7

    Percentage representation of prescribed calories delivered daily via enteral and/or parenteral routes.

  2. Protein delivered daily enterally and/or parenterally

    Time frame: Day 0 to day 7

    Daily administration of protein (in grams) through enteral and/or parenteral routes.

Secondary outcomes

  1. Incidence rate of hospital-acquired infections

    Time frame: 7 days

    Infections acquired in the hospital consist of ventilator-associated pneumonia, bloodstream infections, and infections related to urinary catheters

  2. Percentage of repeated operations

    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.

  3. ICU readmission rate

    Time frame: 90 days

    Occurrences of patients being readmitted to the ICU from within the hospital.

  4. ICU length of stay

    Time frame: 90 days

    Duration of time (days) in the ICU

  5. Duration of mechanical ventilation

    Time frame: 90 days

    Length of time (days) on mechanical ventilation (including still on mechanical ventilation at time of discharge)

  6. Hospital length of stay

    Time frame: 90 days

    Duration of time (days) in the hospital

  7. Parenteral nutrition requirement

    Time frame: Day 0 to day 7

    Parenteral nutrition requirement

  8. 28-day mortality in the ICU

    Time frame: 28 days

    Is the patient alive or deceased 28 days post admission.

Study contacts

Contact information is provided by the study sponsor or research team.

Gustavo Rojas Velasco, MD

CONTACT

[email protected]

+52 55 55732911 ext. 24507

Jacob J Cruz Sánchez, MSc.

CONTACT

[email protected]

+52 5512439841

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Other

Collaborators

  • Instituto Nacional de Enfermedades Respiratorias
  • National Polytechnic Institute, Mexico

Registry information

Official study title

Assessment of Gastrointestinal Dysfunction Through GIDS Scale and Intestinal Damage Biomarkers in Critically Ill Patients Undergoing Aortic Surgery and Its Association With Clinical Outcomes.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2024
Registry last updated
Jul 24, 2024

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.

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