NCT04979494

Brief Summary

Acute gastrointestinal injury (AGI) is related to poor outcomes of critically ill patients \[1\] through many underlying mechanisms \[2\]. It is also a part of the process of multiple organ dysfunction syndrome (MODS). However, the morbidity of acute gastrointestinal dysfunction in critically ill patients is highly underestimated due to the scarcity of accurate measurement and thus the causes are still unclear. In this study, investigators are going to apply the technique of point-of-care ultrasound (POCUS) evaluation on the bowel diameters, wall thickness and movement combined with intra-abdominal pressure to determine the occurrence of AGI. The superior mesenteric artery (SMA) blood flow is also evaluated by POCUS to find out the association between SMA blood flow and AGI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

May 4, 2021

Last Update Submit

August 30, 2024

Conditions

Keywords

Regional blood flowGastrointestinal dysfunctionCritical care

Outcome Measures

Primary Outcomes (1)

  • The occurence of acute gastrointestinal injury

    Gastrointestinal and urinary tract sonography ultrasound (GUTS) score will be calculate using a combination bowel diameter in centimeters, bowel wall thickness in centimeters, peristalsis (with or without) using ultrasound, and intra-abdominal pressure in millimeters of mercury measured through urethral tubes\[3\]. GUTS score is ranging from 0 to 4, and a higher GUTS score means worse gastrointestinal function. A GUTS score more than or equal to 2 is considered as acute gastrointestinal injury(AGI)in this study.

    Within 24 hours after the initiation of enteral feeding

Interventions

We conduct abdominal ultrasound examinations for each patient.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted into the Department of Critical Care Medicine of Peking Union Medical College Hospital, who were eligible of inclusion criteria, were included in the study.

You may qualify if:

  • \~ 80 years old;
  • Under deep sedation (RASS score ≤ -3) with mechanical ventilation at the time of enrollment;
  • Acute Physiology and Chronic Health Evaluation II (APACHE-II) score ≥8.

You may not qualify if:

  • Pregnancy;
  • Recent gastrointestinal surgery;
  • History of acute or chronic gastrointestinal dysfunction before ICU admission;
  • Primary or secondary vascular malformation of SMA;
  • Any contraindication to the use of ultrasound evaluation (e.g., abdominal incision).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Beijing, China

Location

Related Publications (4)

  • Reintam Blaser A, Poeze M, Malbrain ML, Bjorck M, Oudemans-van Straaten HM, Starkopf J; Gastro-Intestinal Failure Trial Group. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Med. 2013 May;39(5):899-909. doi: 10.1007/s00134-013-2831-1. Epub 2013 Jan 31.

    PMID: 23370829BACKGROUND
  • Meng M, Klingensmith NJ, Coopersmith CM. New insights into the gut as the driver of critical illness and organ failure. Curr Opin Crit Care. 2017 Apr;23(2):143-148. doi: 10.1097/MCC.0000000000000386.

    PMID: 28092310BACKGROUND
  • Perko MJ, Madsen P, Perko G, Schroeder TV, Secher NH. Mesenteric artery response to head-up tilt-induced central hypovolaemia and hypotension. Clin Physiol. 1997 Sep;17(5):487-96. doi: 10.1046/j.1365-2281.1997.05252.x.

    PMID: 9347197BACKGROUND
  • Gao T, Cheng MH, Xi FC, Chen Y, Cao C, Su T, Li WQ, Yu WK. Predictive value of transabdominal intestinal sonography in critically ill patients: a prospective observational study. Crit Care. 2019 Nov 27;23(1):378. doi: 10.1186/s13054-019-2645-9.

    PMID: 31775838BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dawei Liu, MSc.

    Peking Union Medical College Hospital, Chinese Academy of Medical Science

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Doctor

Study Record Dates

First Submitted

May 4, 2021

First Posted

July 28, 2021

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 30, 2021

Last Updated

September 4, 2024

Record last verified: 2024-08

Locations