IleusPhase 2NCT01050712
Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
A Phase 2 study testing Inhaled Carbon Monoxide and Synthetic Air in people with Ileus, run by Queen's University at 1 site in Canada.
Trial summary
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ileus
- What is being tested?
- Inhaled Carbon Monoxide and Synthetic Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Sep 2013
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age > 18 years.
- Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
- No prior smoking history.
- BMI between 16 and 30 inclusive.
- No significant abnormalities on history, physical examination or laboratory parameters.
Who cannot join
- Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO.
- Significant disease or disorder (as explained in Study B).
- Complete bowel obstruction.
- Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis).
- Retroperitoneal hematomas.
- Known GI motility disorder.
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- Underlying lung disease such as pneumonia, asthma or COPD.
- Sepsis.
- Planned pregnancy, already pregnant or breastfeeding.
- Electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia).
- Significant opioid and laxative use 4 weeks prior to surgery.
- Anti-inflammatory use 2 days prior to surgery.
- Drugs such as antacids, Coumadin, amitriptyline, chlorpromazine.
- Baseline oxygen saturation <92% on room air.
- Baseline blood level of COHb >2%.
- Baseline hemoglobin <90 g/dL.
- Participation in another clinical trial within 2 months prior to study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.
A preliminary study will be conducted in six healthy volunteers to monitor for blood levels and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation. Length of normal POI and occurrence of POI complications will be compared between the two groups. Side effects that occur from inhaling CO or oxygen will also be recorded.
We hypothesize that inhaling CO before and after colon surgery will shorten the length of normal POI and decrease the occurrence of POI complications with minimal side effects.
- Conditions
- Ileus
- Being tested
- Inhaled Carbon Monoxide, Synthetic Air
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Carbon MonoxideDrug
Concentration of Carbon Monoxide to be inhaled by patients will be determined in a safety trial performed in healthy volunteers prior to the commencement of this trial. Patients randomized to received inhaled carbon monoxide will receive this concentration by cushioned face mask for one hour prior to colon resection and for one hour after colon resection
Synthetic AirDrug
Patients randomized to this intervention will receive this gas via cushioned face mask for one hour prior to colon resection and for one hour after colon resection
| Study group | Role | What they receive |
|---|---|---|
| Carbon Monoxide | Experimental | Not described Receives: Drug: Inhaled Carbon Monoxide |
| Synthetic Air | Placebo comparator | Not described Receives: Drug: Synthetic Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of post operative ileus (radiologic)
Measured: 1 week
Incidence of pathological post operative ileus
Measured: 1 week
Duration of post operative ileus (clinical)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: According to retired PI, resident graduated and next resident never carried it to fruition.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Dr. Paul Belliveau, Queen's University
- Investigators
- Paul J Belliveau, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050712
- Sponsor's protocol ID
- POICO-B
- Status last verified
- Nov 2015
- First submitted
- 14 Jan 2010
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.
- ClinicalTrials.gov ID
- NCT01050712
- Acronym / sponsor ID
- POICO-B
- Conditions
- Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: According to retired PI, resident graduated and next resident never carried it to fruition.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Jan 2010 (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.
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.
A preliminary study will be conducted in six healthy volunteers to monitor for blood levels and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation. Length of normal POI and occurrence of POI complications will be compared between the two groups. Side effects that occur from inhaling CO or oxygen will also be recorded.
We hypothesize that inhaling CO before and after colon surgery will shorten the length of normal POI and decrease the occurrence of POI complications with minimal side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon Monoxide | Experimental | Drug: Inhaled Carbon Monoxide |
| Synthetic Air | Placebo comparator | Drug: Synthetic Air |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age > 18 years.
- Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
- No prior smoking history.
- BMI between 16 and 30 inclusive.
- No significant abnormalities on history, physical examination or laboratory parameters.
Key exclusion criteria (17 listed)
- Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO.
- Significant disease or disorder (as explained in Study B).
- Complete bowel obstruction.
- Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis).
- Retroperitoneal hematomas.
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 |
|---|---|---|
| Inhaled Carbon MonoxideConcentration of Carbon Monoxide to be inhaled by patients will be determined in a safety trial performed in healthy volunteers prior to the commencement of this trial. Patients randomized to received inhaled carbon monoxide will receive this concentration by cushioned face mask for one hour prior to colon resection and for one hour after colon resection | Drug | Carbon Monoxide |
| Synthetic AirPatients randomized to this intervention will receive this gas via cushioned face mask for one hour prior to colon resection and for one hour after colon resection | Drug | Synthetic Air |
Primary outcome
Duration of post operative ileus (radiologic)
Time frame: 1 week
Incidence of pathological post operative ileus
Time frame: 1 week
Duration of post operative ileus (clinical)
Time frame: 1 week
Results and safety
The study was stopped early (reason given: According to retired PI, resident graduated and next resident never carried it to fruition.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Paul J Belliveau, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Carbon Monoxide and Synthetic Air in people with Ileus, run by Queen's University at 1 site in Canada.
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 17 Nov 2015. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study was stopped early (reason given: According to retired PI, resident graduated and next resident never carried it to fruition.). Results are not available in the source record.
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?
Duration of post operative ileus (radiologic) (time frame: 1 week). The study lists 3 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 17 Nov 2015.