NCT06514170

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2024Jun 2026

First Submitted

Initial submission to the registry

July 9, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 23, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

July 9, 2024

Last Update Submit

July 23, 2024

Conditions

Aortic AneurysmGastrointestinal DysfunctionAortic DiseasesEnteral Feeding IntoleranceSurgical Complication

Keywords

Gastrointestinal dysfunctionAortic diseasesAorta surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Incidence rate of hospital-acquired infections

    7 days

  • Percentage of repeated operations

    90 days

  • ICU readmission rate

    90 days

  • ICU length of stay

    90 days

  • Duration of mechanical ventilation

    90 days

  • +3 more secondary outcomes

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23010420BACKGROUND

  • 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.

    PMID: 32414423BACKGROUND

  • 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.

    PMID: 23100540BACKGROUND

  • 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.

    PMID: 34358839BACKGROUND

  • 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.

    PMID: 36958226BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Aortic AneurysmAortic Diseases

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Gustavo Rojas Velasco, MD

    Head of the Cardiovascular Intensive Care Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Rojas Velasco, MD

CONTACT

+52 55 55732911gustavorojas08@gmail.com

Jacob J Cruz Sánchez, MSc.

CONTACT

+52 5512439841jacob.cruz@cardiologia.org.mx

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Cardiovascular Intensive Care Unit

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 23, 2024

Study Start

July 23, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

ME(1)