NCT03589248

Brief Summary

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)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

June 23, 2018

Last Update Submit

July 4, 2018

Conditions

Gastrointestinal DysfunctionCritical IllnessIntestine Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • predict value of 28-day mortality

    predict value of 28-day mortality

    one and a half year

Study Arms (2)

GIF score

assess the AGI by gastrointestinal failure(GIF) score

Diagnostic Test: GIF scoreDiagnostic Test: US score

US score

assess the AGI by ultrasonography(US) score

Diagnostic Test: GIF scoreDiagnostic Test: US score

Interventions

GIF scoreDIAGNOSTIC_TEST

assessment by GIF score

GIF scoreUS score
US scoreDIAGNOSTIC_TEST

assessment by ultrasonography score

GIF scoreUS score

Eligibility Criteria

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

patients with severe complications after surgery and severe trauma

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 31775838DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

June 23, 2018

First Posted

July 17, 2018

Study Start

July 1, 2016

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07