AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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 groups in NCT01919060
Study groupRoleWhat they receive
lesions in colonNot described
lesions in extra-colonNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: 28

Secondary outcomes (1)
  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.

  1. First posted8 Aug 2013 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in