Injury of Other and Multiple Parts of Small IntestineNCT01516359
Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements
An observational study of Injury of Other and Multiple Parts of Small Intestine, run by Cai Li at 1 site in China.
Trial summary
The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Injury of Other and Multiple Parts of Small Intestine
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Nov 2012
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing heart valve replacements under cardiopulmonary bypass
Who may be able to join
- Patients undergoing heart valve replacements under cardiopulmonary bypass
Who cannot join
- Patients who die during or after operation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Ke Xuan Liu, MD, Ph.D., 86-13710684096, liukexuan807@yahoo.com.cn
Cai Li, MD, 86-18602017796, licaigz@yahoo.com.cn
About this study
Official title: Official Title is Required by the WHO and ICMJE
The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.
Read the detailed description
Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with cardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of gut dysfunction
At different time points, gut dysfunction is graded according to previous criterion.
Measured: eight months
Secondary outcomes (2)
The duration of cardiopulmonary bypass
Record the duration of cardiopulmonary bypass
Measured: Eight months
The duration for aortic artery clamping
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Other and Multiple Parts of Small IntestineStudies 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
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cai Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ke Xuan Liu, MD, Ph.D, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516359
- Sponsor's protocol ID
- intestinal injury
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title is Required by the WHO and ICMJE
- ClinicalTrials.gov ID
- NCT01516359
- Acronym / sponsor ID
- intestinal injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cai LiUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 24 Jan 2012 (estimated)
- 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.
The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.
Detailed description
Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with cardiac surgery | – | – |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing heart valve replacements under cardiopulmonary bypass
Key inclusion criteria (1 listed)
- Patients undergoing heart valve replacements under cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Patients who die during or after operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
score of gut dysfunction
Time frame: eight months
At different time points, gut dysfunction is graded according to previous criterion.
2 secondary outcomes
The duration of cardiopulmonary bypass
Time frame: Eight months
The duration for aortic artery clamping
Time frame: eight months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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.
Ke Xuan Liu, MD, Ph.D principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injury of Other and Multiple Parts of Small Intestine, run by Cai Li at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Xuan Liu, MD,Ph.D. (86-20-87755766 ext. 8273, liukexuan807@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of gut dysfunction (time frame: eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2012.