Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto Nacional de Enfermedades Respiratorias | OTHER_GOV |
| National Polytechnic Institute, Mexico | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients following aortic surgery necessitating invasive mechanical ventilation and an intensive care unit stay of ≥ 48 hours.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gustavo Rojas Velasco, MD | Contact | +52 55 55732911 | 24507 | gustavorojas08@gmail.com |
| Jacob J Cruz Sánchez, MSc. | Contact | +52 5512439841 | jacob.cruz@cardiologia.org.mx |
| Name | Affiliation | Role |
|---|---|---|
| Gustavo Rojas Velasco, MD | Head of the Cardiovascular Intensive Care Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cardiología Ignacio Chávez | Recruiting | Mexico City | Tlalpan | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23010420 | Background | 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. | |
| 32414423 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples will be collected, which will then be processed to obtain plasma for the determination of citrulline and I-FABP biomarkers on days 1, 3, and 5 of ICU stay.
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 |
| 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. |
| 23100540 | Background | 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. |
| 34358839 | Background | 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. |
| 36958226 | Background | 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. |