Acute Lower Gastrointestinal DysfunctionPhase 1/2NCT02939508
Should Colon or Non-colon Originated Lesions be Distinguished?
A Phase 1/2 study testing Colon originated: Neostigmin, Colonoscopy decompression, Surgery and Non-colon originated: Neostigmin, Colonoscopy decompression in people with Acute Lower Gastrointestinal Dysfunction, run by Chinese Medical Association at 1 site in China.
Trial summary
This prospective study was designed to compare the difference of effects of conventional treatment, medicine intervention, endoscopic therapy, and surgery between colon originated and non-colon originated ALGID in critical patients, in order to alert doctors to differ the treatment of the two ALGID and provide basis… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Lower Gastrointestinal Dysfunction
- What is being tested?
- Colon originated: Neostigmin, Colonoscopy decompression, Surgery and Non-colon originated: Neostigmin, Colonoscopy decompression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Aug 2017
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in our ICU aged 18-75 years.
- Patients with a confirmed diagnosis of ALGID.
Who cannot join
- mechanical intestinal obstruction (including tumor, stercoral obstruction etc.)
- gastrointestinal hemorrhage within 72 hours.
- history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or radiation enteritis.
- pregnancy.
- contraindications of neostigmine administration.
Trial locations and contacts
1 site in 1 country.
Chenyan Zhao, M.D contact
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210000
Chenyan Zhao, M.D, emmazcy@163.com
About this study
Official title: Acute Lower Gastrointestinal Dysfunction in Critical Care Patients: Should Colon or Non-colon Originated Lesions be Distinguished?
This prospective study was designed to compare the difference of effects of conventional treatment, medicine intervention, endoscopic therapy, and surgery between colon originated and non-colon originated ALGID in critical patients, in order to alert doctors to differ the treatment of the two ALGID and provide basis for treatment.
- Conditions
- Acute Lower Gastrointestinal Dysfunction
- Being tested
- Colon originated: Neostigmin, Colonoscopy decompression, Surgery, Non-colon originated: Neostigmin, Colonoscopy decompression
- Keywords
- Acute lower gastrointestinal dysfunction, Colon-originated lesions, Critical patient, Colonoscopic decompression, Anticholinergic drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon originated: Neostigmin, Colonoscopy decompression, SurgeryOther
Non-colon originated: Neostigmin, Colonoscopy decompressionOther
| Study group | Role | What they receive |
|---|---|---|
| Colon originated | Experimental | A history of colon (-innervating) nerve damage, moderate or more severe edema; and without a history of colon (-innervating) nerve damage, with mild or severe edema of colonic wall on CT. Receives: Other: Colon originated: Neostigmin, Colonoscopy decompression, Surgery |
| Non-colon originated | Active comparator | NCOG met one of the two following criteria:
1. History of nerve damage that could affect colon movement (colon [-innervating] nerve damage), such as pelvic or retroperitoneal operation, spine injury, or cerebral lesion; and non-existing or mild edema of colonic wall on abdominal CT;
2. Absence of history of colon(-innervating) nerve damage, with no obvious change in the colonic wall visible on the CT scan. Receives: Other: Non-colon originated: Neostigmin, Colonoscopy decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality after admission
Measured: 1-28 day after admission
ICU mortality, n (%)
Measured: 1-28 day after ICU admission
Secondary outcomes (4)
ICU stage, (day)
Measured: 1-60 day after ICU admission
Hospitalization, (day)
Measured: 1-60 day after admission
intra-abdominal pressure
Measured: 1-28 day after admission
Abdominal compartment syndrome
Measured: 1-28 day after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lower 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Juanhong Shen, Chinese Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939508
- Sponsor's protocol ID
- Jinling37ICUZCY
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lower Gastrointestinal Dysfunction in Critical Care Patients: Should Colon or Non-colon Originated Lesions be Distinguished?
- ClinicalTrials.gov ID
- NCT02939508
- Acronym / sponsor ID
- Jinling37ICUZCY
- Conditions
- Acute Lower Gastrointestinal Dysfunction
- Keywords
- Acute lower gastrointestinal dysfunction, Colon-originated lesions, Critical patient, Colonoscopic decompression, Anticholinergic drugs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 20 Oct 2016 (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.
This prospective study was designed to compare the difference of effects of conventional treatment, medicine intervention, endoscopic therapy, and surgery between colon originated and non-colon originated ALGID in critical patients, in order to alert doctors to differ the treatment of the two ALGID and provide basis for treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colon originated | Experimental | Other: Colon originated: Neostigmin, Colonoscopy decompression, SurgeryA history of colon (-innervating) nerve damage, moderate or more severe edema; and without a history of colon (-innervating) nerve damage, with mild or severe edema of colonic wall on CT. |
| Non-colon originated | Active comparator | Other: Non-colon originated: Neostigmin, Colonoscopy decompressionNCOG met one of the two following criteria: 1. History of nerve damage that could affect colon movement (colon [-innervating] nerve damage), such as pelvic or retroperitoneal operation, spine injury, or cerebral lesion; and non-existing or mild edema of colonic wall on abdominal CT; 2. Absence of history of colon(-innervating) nerve damage, with no obvious change in the colonic wall visible on the CT scan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in our ICU aged 18-75 years.
- Patients with a confirmed diagnosis of ALGID.
Key exclusion criteria (5 listed)
- mechanical intestinal obstruction (including tumor, stercoral obstruction etc.)
- gastrointestinal hemorrhage within 72 hours.
- history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or radiation enteritis.
- pregnancy.
- contraindications of neostigmine administration.
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 |
|---|---|---|
| Colon originated: Neostigmin, Colonoscopy decompression, Surgery | Other | Colon originated |
| Non-colon originated: Neostigmin, Colonoscopy decompression | Other | Non-colon originated |
Primary outcome
28-day mortality after admission
Time frame: 1-28 day after admission
ICU mortality, n (%)
Time frame: 1-28 day after ICU admission
4 secondary outcomes
ICU stage, (day)
Time frame: 1-60 day after ICU admission
Hospitalization, (day)
Time frame: 1-60 day after admission
intra-abdominal pressure
Time frame: 1-28 day after admission
Abdominal compartment syndrome
Time frame: 1-28 day after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Individual participant dataSharing planned: Undecided
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.
Chenyan Zhao, M.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Colon originated: Neostigmin, Colonoscopy decompression, Surgery and Non-colon originated: Neostigmin, Colonoscopy decompression in people with Acute Lower Gastrointestinal Dysfunction, run by Chinese Medical Association 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 2 inclusion and 5 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 20 Oct 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chenyan Zhao, M.D (emmazcy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality after admission (time frame: 1-28 day after admission). The study lists 2 primary outcomes in all. 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 20 Oct 2016.