Gastrointestinal DysfunctionNCT03589248
Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients
An observational study of Gastrointestinal Dysfunction and Critical Illness, run by Nanjing PLA General Hospital.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Dysfunction, Critical Illness, Intestine Ultrasonography
- What is being tested?
- GIF score and US score
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with severe complications after surgery and severe trauma
Who may be able to join
- aged more than 18 years
- Acute Physiology Chronic Health Evaluation II (APACHE II) score >8
Who cannot join
- uncontrolled mesenteric vascular disease
- uncontrolled chronic organ dysfunction
- advanced cancer
- any terminal stage disease
About this study
Official title: 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)
- Being tested
- GIF score, US score
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIF scoreDiagnostic test
assessment by GIF score
US scoreDiagnostic test
assessment by ultrasonography score
| Study group | Role | What they receive |
|---|---|---|
| GIF score | assess the AGI by gastrointestinal failure(GIF) score Receives: Diagnostic Test: GIF score; Diagnostic Test: US score | |
| US score | assess the AGI by ultrasonography(US) score Receives: Diagnostic Test: GIF score; Diagnostic Test: US score |
What is being measured
The primary outcome is the main question the study is designed to answer.
predict value of 28-day mortality
predict value of 28-day mortality
Measured: one and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jul 2016
- Primary completion1 Jan 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Tao, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589248
- Sponsor's protocol ID
- 2016NLYZDRC015
- Status last verified
- Jul 2018
- First submitted
- 23 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31775838
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Transabdominal Intestine Sonography in Critically Ill Patients：A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03589248
- Acronym / sponsor ID
- 2016NLYZDRC015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIF score | – | Diagnostic Test: GIF score, Diagnostic Test: US scoreassess the AGI by gastrointestinal failure(GIF) score |
| US score | – | Diagnostic Test: GIF score, Diagnostic Test: US scoreassess the AGI by ultrasonography(US) score |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe complications after surgery and severe trauma
Key inclusion criteria (2 listed)
- aged more than 18 years
- Acute Physiology Chronic Health Evaluation II (APACHE II) score >8
Key exclusion criteria (4 listed)
- uncontrolled mesenteric vascular disease
- uncontrolled chronic organ dysfunction
- advanced cancer
- any terminal stage disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIF scoreassessment by GIF score | Diagnostic test | GIF score, US score |
| US scoreassessment by ultrasonography score | Diagnostic test | GIF score, US score |
Primary outcome
predict value of 28-day mortality
Time frame: one and a half year
predict value of 28-day mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Derived from this study: PubMed 31775838Gao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Dysfunction and Critical Illness, run by Nanjing PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predict value of 28-day mortality (time frame: one and a half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.