Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589248
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Gao Tao, Nanjing PLA General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Condition or disease Intervention/treatment
Gastrointestinal Dysfunction Critical Illness Intestine Ultrasonography Diagnostic Test: GIF score Diagnostic Test: US score

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients：A Prospective, Observational Study
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : April 1, 2018
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. predict value of 28-day mortality [ Time Frame: one and a half year ]
    predict value of 28-day mortality


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with severe complications after surgery and severe trauma
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Gao Tao, research assistant, Nanjing PLA General Hospital
ClinicalTrials.gov Identifier: NCT03589248    
Other Study ID Numbers: 2016NLYZDRC015
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes