Gastrointestinal Dysfunction in Aortic Surgery Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Dysfunction; Aortic Aneurysm; Aortic Diseases; Surgical Complication; Enteral Feeding Intolerance
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 114

Contacts and Locations

• Study Contact: Name: Gustavo Rojas Velasco, MD; Phone Number: 24507 +52 55 55732911; Email: gustavorojas08@gmail.com
• Study Contact Backup: Name: Jacob J Cruz Sánchez, MSc.; Phone Number: +52 5512439841; Email: jacob.cruz@cardiologia.org.mx

Study Locations

• Mexico
  • Tlalpan
    • Ciudad de mexico, Tlalpan, Mexico, 14080
      • Recruiting
      • Instituto Nacional de Cardiologia Ignacio Chavez
      • Contact: Gustavo Rojas Velasco, MD; Phone Number: 24507 +52 55 55732911; Email: gustavorojas08@gmail.com
      • Contact: Jacob J Cruz Sánchez, MSc; Phone Number: +52 5512439841; Email: jacob.cruz@cardiologia.org.mx
      • Sub-Investigator: Jacob J Cruz Sánchez, MSc
      • Sub-Investigator: Daniel Manzur Sandoval, MD
      • Sub-Investigator: Carla G Aguilar Rodríguez, MD
      • Sub-Investigator: Eduardo A Escudero González, MD
      • Sub-Investigator: María L Tovar Hernández, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calories delivered daily enterally and/or parenterally	Percentage representation of prescribed calories delivered daily via enteral and/or parenteral routes.	Day 0 to day 7
Protein delivered daily enterally and/or parenterally	Daily administration of protein (in grams) through enteral and/or parenteral routes.	Day 0 to day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of hospital-acquired infections	Infections acquired in the hospital consist of ventilator-associated pneumonia, bloodstream infections, and infections related to urinary catheters	7 days
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.	90 days
ICU readmission rate	Occurrences of patients being readmitted to the ICU from within the hospital.	90 days
ICU length of stay	Duration of time (days) in the ICU	90 days
Duration of mechanical ventilation	Length of time (days) on mechanical ventilation (including still on mechanical ventilation at time of discharge)	90 days
Hospital length of stay	Duration of time (days) in the hospital	90 days
Parenteral nutrition requirement	Parenteral nutrition requirement	Day 0 to day 7
28-day mortality in the ICU	Is the patient alive or deceased 28 days post admission.	28 days

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Collaborators: National Polytechnic Institute, Mexico; Instituto Nacional de Enfermedades Respiratorias
• Investigators: Principal Investigator: Gustavo Rojas Velasco, MD, Head of the Cardiovascular Intensive Care Unit

Publications and helpful links

General Publications

• Reintam Blaser A, Padar M, Mandul M, Elke G, Engel C, Fischer K, Giabicani M, Gold T, Hess B, Hiesmayr M, Jakob SM, Loudet CI, Meesters DM, Mongkolpun W, Paugam-Burtz C, Poeze M, Preiser JC, Renberg M, Rooijackers O, Tamme K, Wernerman J, Starkopf J. Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study). Clin Nutr. 2021 Aug;40(8):4932-4940. doi: 10.1016/j.clnu.2021.07.015. Epub 2021 Jul 18.
• Stoppe C, Spillner J, Rossaint R, Coburn M, Schalte G, Wildenhues A, Marx G, Rex S. Selenium blood concentrations in patients undergoing elective cardiac surgery and receiving perioperative sodium selenite. Nutrition. 2013 Jan;29(1):158-65. doi: 10.1016/j.nut.2012.05.013. Epub 2012 Sep 23.
• Reintam Blaser A, Preiser JC, Fruhwald S, Wilmer A, Wernerman J, Benstoem C, Casaer MP, Starkopf J, van Zanten A, Rooyackers O, Jakob SM, Loudet CI, Bear DE, Elke G, Kott M, Lautenschlager I, Schaper J, Gunst J, Stoppe C, Nobile L, Fuhrmann V, Berger MM, Oudemans-van Straaten HM, Arabi YM, Deane AM; Working Group on Gastrointestinal Function within the Section of Metabolism, Endocrinology and Nutrition (MEN Section) of ESICM. 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. Crit Care. 2020 May 15;24(1):224. doi: 10.1186/s13054-020-02889-4.
• van Zanten AR. Nutrition barriers in abdominal aortic surgery: a multimodal approach for gastrointestinal dysfunction. JPEN J Parenter Enteral Nutr. 2013 Mar;37(2):172-7. doi: 10.1177/0148607112464499. Epub 2012 Oct 24. No abstract available.
• Liu X, Wang Q, Yang D, Fu M, Yang M, Bi Y, Wang C, Song X. Association between Gastrointestinal Dysfunction Score (GIDS) and disease severity and prognosis in critically ill patients: A prospective, observational study. Clin Nutr. 2023 May;42(5):700-705. doi: 10.1016/j.clnu.2023.03.004. Epub 2023 Mar 7.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Aortic diseases; Gastrointestinal dysfunction; Aorta surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Aneurysm; Aortic Diseases
• Other Study ID Numbers: 24-1427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No