Clinical trial NCT06514170: Gastrointestinal Dysfunction in Aortic Surgery Patients
Official 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm
Gastrointestinal Dysfunction
Aortic Diseases
Enteral Feeding Intolerance
Surgical Complication
Keywords: Gastrointestinal dysfunction
Aortic diseases
Aorta surgery
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Enfermedades Respiratorias
name: National Polytechnic Institute, Mexico
First posted: 2024-07-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients following aortic surgery necessitating invasive mechanical ventilation and an intensive care unit stay of ≥ 48 hours.

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.

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.

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.

Primary outcomes:
measure: Calories delivered daily enterally and/or parenterally
timeFrame: Day 0 to day 7
measure: Protein delivered daily enterally and/or parenterally
timeFrame: Day 0 to day 7
Secondary outcomes:
measure: Incidence rate of hospital-acquired infections
timeFrame: 7 days
measure: Percentage of repeated operations
timeFrame: 90 days
measure: ICU readmission rate
timeFrame: 90 days
measure: ICU length of stay
timeFrame: 90 days
measure: Duration of mechanical ventilation
timeFrame: 90 days
measure: Hospital length of stay
timeFrame: 90 days
measure: Parenteral nutrition requirement
timeFrame: Day 0 to day 7
measure: 28-day mortality in the ICU
timeFrame: 28 days
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Instituto Nacional de Cardiología Ignacio Chávez
state: Tlalpan
Study officials:
affiliation: Head of the Cardiovascular Intensive Care Unit
name: Gustavo Rojas Velasco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.