Actively Recruiting

Age: 18Years +
All Genders
ID06514170

Assessment of Gastrointestinal Dysfunction Using GIDS and Biomarkers in Critically Ill Patients Post-Aortic Surgery

Led by Instituto Nacional de Cardiologia Ignacio Chavez · Updated on 2024-07-24

114

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

I

Instituto Nacional de Cardiologia Ignacio Chavez

Lead Sponsor

I

Instituto Nacional de Enfermedades Respiratorias

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to study gastrointestinal dysfunction in critically ill patients undergoing aortic surgery. It seeks to understand the relationship between GI dysfunction, measured using the Gastrointestinal Dysfunction Scale (GIDS) and biomarkers like citrulline and Intestinal fatty-acid binding protein (I-FABP), with nutrition delivery and important ICU outcomes. The study recognizes the high risk of complications and mortality in these patients, emphasizing early detection to guide nutritional therapy and improve clinical results. Participants in this observational study will not receive any intervention. Instead, researchers will assess GI dysfunction using the GIDS tool and measure serum levels of citrulline and I-FABP. The study focuses on patients after elective or urgent aortic surgery requiring cardiopulmonary bypass and extended mechanical ventilation. Nutritional intake including calories and protein delivered enterally or parenterally will be monitored daily from day 0 to day 7 post-surgery. During the study, participants will be closely observed in the ICU for clinical outcomes such as infection rates, need for repeated operations, length of ICU and hospital stays, duration of mechanical ventilation, parenteral nutrition requirement, and 28-day mortality in the ICU. Data collection includes monitoring nutritional delivery and recording complications up to 90 days after surgery. The study aims to identify early signs of GI dysfunction to improve care and patient quality of life during the critical postoperative period.

CONDITIONS

Brief Title

Gastrointestinal Dysfunction in Aortic Surgery Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Patients who have undergone elective or urgent aortic surgery with cardiopulmonary bypass
  • Expected need for invasive mechanical ventilation for more than 48 hours
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Pre-existing gastrointestinal issues while on mechanical ventilation
  • Diagnosis of adult congenital heart disease
  • Pregnancy or lactation
  • Participation in another clinical study involving experimental therapy
  • Presence of chronic intestinal disease
  • Previous gastrointestinal conditions detected during nutritional screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 7 days

Participants are observed after aortic surgery to assess gastrointestinal dysfunction using the Gastrointestinal Dysfunction Scale (GIDS) and biomarkers such as citrulline and I-FABP. Nutritional intake and related outcomes are tracked during this period.

Daily assessments for up to 7 days

Long-term Monitoring

Duration - Up to 90 days

Participants are followed for up to 90 days after surgery to monitor hospital-acquired infections, ICU readmission, length of stay, mechanical ventilation duration, repeated operations, and mortality outcomes.

Periodic visits and assessments up to 90 days

Trial Site Locations

Total: 1 location

1

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Tlalpan, Mexico, 14080

Actively Recruiting

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Research Team

G

Gustavo Rojas Velasco, MD

J

Jacob J Cruz Sánchez, MSc.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Selenium blood concentrations in patients undergoing elective cardiac surgery and receiving perioperative sodium selenite.

Christian Stoppe, Jan Spillner, Rolf Rossaint...

https://pubmed.ncbi.nlm.nih.gov/23010420

Gastrointestinal dysfunction in the critically ill: a systematic scoping review and research agenda proposed by the Section of Metabolism, Endocrinology and Nutrition of the European Society of Intensive Care Medicine.

Annika Reintam Blaser, Jean-Charles Preiser, Sonja Fruhwald...

https://pubmed.ncbi.nlm.nih.gov/32414423

Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study).

Annika Reintam Blaser, Martin Padar, Merli Mändul...

https://pubmed.ncbi.nlm.nih.gov/34358839

Association between Gastrointestinal Dysfunction Score (GIDS) and disease severity and prognosis in critically ill patients: A prospective, observational study.

Xinyan Liu, Qizhi Wang, Daqiang Yang...

https://pubmed.ncbi.nlm.nih.gov/36958226