Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients

Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients：A Prospective, Observational Study

It is very important to evaluate the degree of gastrointestinal dysfunction in critical ill patients. Thus the investigators conducted transabdominal intestine ultrasonography(US) in critical ill patients to evaluated the degree of gastrointestinal dysfunction under the acute gastrointestinal injury (AGI)

Study Overview

• Status: Completed
• Conditions: Critical Illness; Gastrointestinal Dysfunction; Intestine Ultrasonography
• Intervention / Treatment: Diagnostic test: GIF score; Diagnostic test: US score

• Study Type: Observational
• Enrollment (Actual): 136

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with severe complications after surgery and severe trauma

Description

Inclusion Criteria:

• aged more than 18 years
• Acute Physiology Chronic Health Evaluation II (APACHE II) score >8

Exclusion Criteria:

• uncontrolled mesenteric vascular disease
• uncontrolled chronic organ dysfunction
• advanced cancer
• any terminal stage disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GIF score; assess the AGI by gastrointestinal failure(GIF) score	Diagnostic test: GIF score; assessment by GIF score; Diagnostic test: US score; assessment by ultrasonography score
US score; assess the AGI by ultrasonography(US) score	Diagnostic test: GIF score; assessment by GIF score; Diagnostic test: US score; assessment by ultrasonography score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predict value of 28-day mortality	predict value of 28-day mortality	one and a half year

Collaborators and Investigators

• Sponsor: Nanjing PLA General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: June 23, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2016NLYZDRC015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No