Gastrointestinal Dysfunction in Aortic Surgery Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto Nacional de Cardiologia Ignacio Chavez

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult patients following aortic surgery necessitating invasive mechanical ventilation and an intensive care unit stay of ≥ 48 hours.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Calories delivered daily enterally and/or parenterally

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

Time frame
Day 0 to day 7
2

Protein delivered daily enterally and/or parenterally

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

Time frame
Day 0 to day 7

Secondary outcomes

1

Incidence rate of hospital-acquired infections

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

Time frame
7 days
2

Percentage of repeated operations

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
3

ICU readmission rate

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

Time frame
90 days
4

ICU length of stay

Duration of time (days) in the ICU

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Nacional de Cardiologia Ignacio Chavez

Lead sponsor

Instituto Nacional de Enfermedades Respiratorias

Collaborator

National Polytechnic Institute, Mexico

Collaborator