Aortic AneurysmNCT06514170
Gastrointestinal Dysfunction in Aortic Surgery Patients
An observational study of Aortic Aneurysm and Gastrointestinal Dysfunction, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Gastrointestinal Dysfunction, Aortic Diseases
- How many people
- 114 participants
- Where
- 1 siteMexico
- Study dates
- 23 Jul 2024to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients following aortic surgery necessitating invasive mechanical ventilation and an intensive care unit stay of ≥ 48 hours.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Tlalpan, 14080
Gustavo Rojas Velasco, MD, +52 55 55732911 ext. 24507, gustavorojas08@gmail.com
Jacob J Cruz Sánchez, MSc, +52 5512439841, jacob.cruz@cardiologia.org.mx
About this study
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.
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Gastrointestinal Dysfunction, Aortic Diseases, Enteral Feeding Intolerance, Surgical Complication
- Being tested
- No intervention
- Keywords
- Gastrointestinal dysfunction, Aortic diseases, Aorta surgery
- Medical subject headings
- Aortic Aneurysm, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories delivered daily enterally and/or parenterally
Percentage representation of prescribed calories delivered daily via enteral and/or parenteral routes.
Measured: Day 0 to day 7
Protein delivered daily enterally and/or parenterally
Daily administration of protein (in grams) through enteral and/or parenteral routes.
Measured: Day 0 to day 7
Secondary outcomes (8)
Incidence rate of hospital-acquired infections
Infections acquired in the hospital consist of ventilator-associated pneumonia, bloodstream infections, and infections related to urinary catheters
Measured: 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.
Measured: 90 days
ICU readmission rate
Occurrences of patients being readmitted to the ICU from within the hospital.
Measured: 90 days
ICU length of stay
Duration of time (days) in the ICU
Measured: 90 days
Duration of mechanical ventilation
Length of time (days) on mechanical ventilation (including still on mechanical ventilation at time of discharge)
Measured: 90 days
Hospital length of stay
Duration of time (days) in the hospital
Measured: 90 days
Parenteral nutrition requirement
Parenteral nutrition requirement
Measured: Day 0 to day 7
28-day mortality in the ICU
Is the patient alive or deceased 28 days post admission.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start23 Jul 2024
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Enfermedades Respiratorias, National Polytechnic Institute, Mexico
- Responsible party
- Principal investigator, Gustavo Rojas Velasco, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Gustavo Rojas Velasco, MD, Principal investigator, Head of the Cardiovascular Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514170
- Sponsor's protocol ID
- 24-1427
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23010420Reintam 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.
PubMed 32414423van 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.
PubMed 23100540Reintam 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.
PubMed 34358839Liu 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.
PubMed 36958226
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06514170
- Acronym / sponsor ID
- 24-1427
- Conditions
- Aortic Aneurysm, Gastrointestinal Dysfunction, Aortic Diseases, Enteral Feeding Intolerance, Surgical Complication
- Keywords
- Gastrointestinal dysfunction, Aortic diseases, Aorta surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- Instituto Nacional de Enfermedades Respiratorias, National Polytechnic Institute, Mexico
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients following aortic surgery necessitating invasive mechanical ventilation and an intensive care unit stay of ≥ 48 hours.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Calories delivered daily enterally and/or parenterally
Time frame: Day 0 to day 7
Percentage representation of prescribed calories delivered daily via enteral and/or parenteral routes.
Protein delivered daily enterally and/or parenterally
Time frame: Day 0 to day 7
Daily administration of protein (in grams) through enteral and/or parenteral routes.
8 secondary outcomes
Incidence rate of hospital-acquired infections
Time frame: 7 days
Percentage of repeated operations
Time frame: 90 days
ICU readmission rate
Time frame: 90 days
ICU length of stay
Time frame: 90 days
Duration of mechanical ventilation
Time frame: 90 days
Hospital length of stay
Time frame: 90 days
Parenteral nutrition requirement
Time frame: Day 0 to day 7
28-day mortality in the ICU
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 23010420Stoppe 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.
- Background: PubMed 32414423Reintam 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.
- Background: PubMed 23100540van 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.
- Background: PubMed 34358839Reintam 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.
- Background: PubMed 36958226Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Rojas Velasco, MD principal investigator
Head of the Cardiovascular Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Gastrointestinal Dysfunction, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo Rojas Velasco, MD (+52 55 55732911 ext. 24507, gustavorojas08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calories delivered daily enterally and/or parenterally (time frame: Day 0 to day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514170, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.