Critical Care Patient; Lower Digestive Tract Disorder;NCT01919060
Acute Non-mechanical Lower Digestive Tract Disorders Should Distinguish Whether Colonic Lesions or Not in Critically Ill Patients
An observational study of Critical Care Patient; Lower Digestive Tract Disorder; and Colon Lesions;, run by Nanjing PLA General Hospital.
Trial summary
The purpose of the study is to investigate acute non-mechanical lower digestive tract disorders should distinguish whether colonic lesions or not in critically ill patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Care Patient; Lower Digestive Tract Disorder;, Colon Lesions;
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was approved by the ethics committee of Jinling hospital and the medical school of nanjing university. This prospective study was performed at a surgical intensive care unit (SICU), which contain 39 beds, of general surgical departement of Jinling hospital, affiliated hospital of medical school of nanjing university. Written informed consents were obtained from the patients or their next of kin. Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction were recrutied to the study.
Who may be able to join
- Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction
- enteral nutrition intolerance not due to upper gastriointestinal obstruction
- Colonic distension: colonic diameter >6 cm or ileocecus diameter >9 cm under the view of computed tomography or abdomial X ray. Enteral nutrition intolerance was defined as enteral feeding < 50% caculated needs or no feeding for three days -
Who cannot join
- mechanical intestinal obstruction (including tomor, stercoral obstruction etc); gastrointestinal hemorrhage within 72 hours; history of inflammatory bowel disease (ulcerative colitis or crohn's disease) or radiation enteritis; pregnancy; having the contradiction of proserine administration. -
About this study
The purpose of the study is to investigate acute non-mechanical lower digestive tract disorders should distinguish whether colonic lesions or not in critically ill patients
Read the detailed description
The study was approved by the ethics committee of Jinling hospital and the medical school of nanjing university. This prospective study was performed at a surgical intensive care unit (SICU), which contain 39 beds, of general surgical departement of Jinling hospital, affiliated hospital of medical school of nanjing university. Written informed consents were obtained from the patients or their next of kin.
Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction were recrutied to the study. The two following criterias should met for the diagnosis of acute lower gastrointestinal dysfunction: 1. enteral nutrition intolerance not due to upper gastriointestinal obstruction; 2. Colonic distension: colonic diameter >6 cm or ileocecus diameter >9 cm under the view of computed tomography or abdomial X ray. Enteral nutrition intolerance was defined as enteral feeding < 50% caculated needs or no feeding for three days.
Patients with following conditions were excluded: mechanical intestinal obstruction (including tomor, stercoral obstruction etc); gastrointestinal hemorrhage within 72 hours; history of inflammatory bowel disease (ulcerative colitis or crohn's disease) or radiation enteritis; pregnancy; having the contradiction of proserine administration.
Data on demagraphy, diagnosis, treatment as well as APACHE Ⅱ and SOFA score within 24 hs of admission were recorded. The included patients were examined by contrast-enhanced abdominal CT, and were devided into two groups, colon oriented group and non-colon oriented group, independently by 2 professionals combining the history and CT results. Non-colon oriented group should met one of the two following crieria: 1. with a history of nerves damage which affect colon movement (colon(-innervating) nerves damage) (such as pevic or retroperitoneal operation, spine injury, cerebral lesion), and non- or mild edema of colonic wall presented on abdominal CT; 2. without a history of colon(-innervating) nerves damage, whereas no obvious change can be seen on CT scan. The others were clarified as colon-oriented group (namely, with a history of colon(-innervating) nerves damage, moderate or more severe edema; without a history of colon(-innervating) nerves damage, whereas mild or sever edema presented ).
All the patients diagnosed with acute lower gastrointestinal dysfunction were treated according to the protocol depicted in figure 1.
Conservative treatment: firstly, hydro-electrolyte and thyroid function were assessed, and corrected if abnormal. Maintain the blood glucose at the normal level. Patients proning to be diagnosed with sepsis were adminstered antibiotics empirically, and adjusted to more targeted antibiotics according to the ensuing result of blood culture and drug sensitive test. Patients were subject to fasting, gastrointestinal decompression via stomach and anal tube. Gastric residual volume (GRV) was assessed per diem. Pharmaceuticals impacting bowel movement were suspended as far as possible, such as opiate, anticholinergic drugs, and calcium channel blockers (CCB). Intravenous administration of proserine was considered if cecum diameter > 10 cm after the treatement described above and show no signs of ameliaration in 24 h.
Colonoscopic decompression: colonoscopic decompression was applied when obvious cecum distension existed (diameter > 10) more than 3 days, and no signs of improvement gained after 24-48 hs of conservative treatment or contradiction of proserine existed. Colonoscopic decompression was performed by 2 experienced endoscopic physicians at the bedside or in the endoscope room.
Surgical intervention: surgery was indicated when colonic diatension lasted more than 6 days, or obvious cecal distention (diameter > 10 cm) continued after 48-72 hs of conservative management and colonoscopic decompression ???or with contradiction of colonoscopy. ileostomy was performed under epidural or local anesthesia by a team of experienced surgeons. If the patients had colonic necrosis or perforation, ileostomy was superseded by colectomy under general anesthesia.
In the SICU, bladder pressure was measured everaday to reflect intraabdominal pressure. And patients received CT examination at day 1, day 3, day 5 and every eusing week, other than additional illness-required CT. The measurement of colonic or cecum diameter, and assessment of intestional eddema, ischemia and perforation were performed by two trained fellows to record the recovery time. Criteria for colonic recovery were as follows: 1.enteral nutrition reached or surpass 50% of targeted needs more than 3 days; 2. Restoration of normal aerofluxus and defecation; 3. Significant improvent of colonic distension or colonic wall was shown on abdominal CT (colonic diameter < 6 cm or cecum diameter < 9 cm).
Recurrence was defined as, patients rediagnosed with acute lower gastrointestional dysfunction within 72 hrs of recovery after a certain treatment(s).
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 |
|---|---|---|
| lesions in colon | Not described | |
| lesions in extra-colon | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 28
Secondary outcomes (1)
Organ failure or dysfunction
Measured: 28day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startJan 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care Patient; Lower Digestive Tract Disorder;Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 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
- NCT01919060
- Sponsor's protocol ID
- 2007NLY099
- Status last verified
- Jan 2007
- First submitted
- 6 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Non-mechanical Lower Digestive Tract Disorders Should Distinguish Whether Colonic Lesions or Not in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01919060
- Acronym / sponsor ID
- 2007NLY099
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Nanjing PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Aug 2013 (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 the study is to investigate acute non-mechanical lower digestive tract disorders should distinguish whether colonic lesions or not in critically ill patients
Detailed description
The study was approved by the ethics committee of Jinling hospital and the medical school of nanjing university. This prospective study was performed at a surgical intensive care unit (SICU), which contain 39 beds, of general surgical departement of Jinling hospital, affiliated hospital of medical school of nanjing university. Written informed consents were obtained from the patients or their next of kin.
Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction were recrutied to the study. The two following criterias should met for the diagnosis of acute lower gastrointestinal dysfunction: 1. enteral nutrition intolerance not due to upper gastriointestinal obstruction; 2. Colonic distension: colonic diameter >6 cm or ileocecus diameter >9 cm under the view of computed tomography or abdomial X ray. Enteral nutrition intolerance was defined as enteral feeding < 50% caculated needs or no feeding for three days.
Patients with following conditions were excluded: mechanical intestinal obstruction (including tomor, stercoral obstruction etc); gastrointestinal hemorrhage within 72 hours; history of inflammatory bowel disease (ulcerative colitis or crohn's disease) or radiation enteritis; pregnancy; having the contradiction of proserine administration.
Data on demagraphy, diagnosis, treatment as well as APACHE Ⅱ and SOFA score within 24 hs of admission were recorded. The included patients were examined by contrast-enhanced abdominal CT, and were devided into two groups, colon oriented group and non-colon oriented group, independently by 2 professionals combining the history and CT results. Non-colon oriented group should met one of the two following crieria: 1. with a history of nerves damage which affect colon movement (colon(-innervating) nerves damage) (such as pevic or retroperitoneal operation, spine injury, cerebral lesion), and non- or mild edema of colonic wall presented on abdominal CT; 2. without a history of colon(-innervating) nerves damage, whereas no obvious change can be seen on CT scan. The others were clarified as colon-oriented group (namely, with a history of colon(-innervating) nerves damage, moderate or more severe edema; without a history of colon(-innervating) nerves damage, whereas mild or sever edema presented ).
All the patients diagnosed with acute lower gastrointestinal dysfunction were treated according to the protocol depicted in figure 1.
Conservative treatment: firstly, hydro-electrolyte and thyroid function were assessed, and corrected if abnormal. Maintain the blood glucose at the normal level. Patients proning to be diagnosed with sepsis were adminstered antibiotics empirically, and adjusted to more targeted antibiotics according to the ensuing result of blood culture and drug sensitive test. Patients were subject to fasting, gastrointestinal decompression via stomach and anal tube. Gastric residual volume (GRV) was assessed per diem. Pharmaceuticals impacting bowel movement were suspended as far as possible, such as opiate, anticholinergic drugs, and calcium channel blockers (CCB). Intravenous administration of proserine was considered if cecum diameter > 10 cm after the treatement described above and show no signs of ameliaration in 24 h.
Colonoscopic decompression: colonoscopic decompression was applied when obvious cecum distension existed (diameter > 10) more than 3 days, and no signs of improvement gained after 24-48 hs of conservative treatment or contradiction of proserine existed. Colonoscopic decompression was performed by 2 experienced endoscopic physicians at the bedside or in the endoscope room.
Surgical intervention: surgery was indicated when colonic diatension lasted more than 6 days, or obvious cecal distention (diameter > 10 cm) continued after 48-72 hs of conservative management and colonoscopic decompression ???or with contradiction of colonoscopy. ileostomy was performed under epidural or local anesthesia by a team of experienced surgeons. If the patients had colonic necrosis or perforation, ileostomy was superseded by colectomy under general anesthesia.
In the SICU, bladder pressure was measured everaday to reflect intraabdominal pressure. And patients received CT examination at day 1, day 3, day 5 and every eusing week, other than additional illness-required CT. The measurement of colonic or cecum diameter, and assessment of intestional eddema, ischemia and perforation were performed by two trained fellows to record the recovery time. Criteria for colonic recovery were as follows: 1.enteral nutrition reached or surpass 50% of targeted needs more than 3 days; 2. Restoration of normal aerofluxus and defecation; 3. Significant improvent of colonic distension or colonic wall was shown on abdominal CT (colonic diameter < 6 cm or cecum diameter < 9 cm).
Recurrence was defined as, patients rediagnosed with acute lower gastrointestional dysfunction within 72 hrs of recovery after a certain treatment(s).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lesions in colon | – | – |
| lesions in extra-colon | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was approved by the ethics committee of Jinling hospital and the medical school of nanjing university. This prospective study was performed at a surgical intensive care unit (SICU), which contain 39 beds, of general surgical departement of Jinling hospital, affiliated hospital of medical school of nanjing university. Written informed consents were obtained from the patients or their next of kin. Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction were recrutied to the study.
Key inclusion criteria (3 listed)
- Critical patients aging from 18 to 80 years old diagnosed with acute lower gastrointestinal dysfunction
- enteral nutrition intolerance not due to upper gastriointestinal obstruction
- Colonic distension: colonic diameter >6 cm or ileocecus diameter >9 cm under the view of computed tomography or abdomial X ray. Enteral nutrition intolerance was defined as enteral feeding < 50% caculated needs or no feeding for three days -
Key exclusion criteria (1 listed)
- mechanical intestinal obstruction (including tomor, stercoral obstruction etc); gastrointestinal hemorrhage within 72 hours; history of inflammatory bowel disease (ulcerative colitis or crohn's disease) or radiation enteritis; pregnancy; having the contradiction of proserine administration. -
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
All cause mortality
Time frame: 28
1 secondary outcome
Organ failure or dysfunction
Time frame: 28day
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 8 Aug 2013.
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 Critical Care Patient; Lower Digestive Tract Disorder; and Colon Lesions;, 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 3 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: finished, as of the sponsor's last update on 8 Aug 2013. 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?
All cause mortality (time frame: 28). 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 8 Aug 2013.