Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Queen's University
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT01050712
First received: January 14, 2010
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Ileus
Drug: Inhaled Carbon Monoxide
Drug: Synthetic Air
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Duration of post operative ileus (radiologic) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Incidence of pathological post operative ileus [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Duration of post operative ileus (clinical) [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbon Monoxide Drug: Inhaled Carbon Monoxide
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
Placebo Comparator: Synthetic Air Drug: Synthetic Air
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050712

Contacts
Contact: Paul J Belliveau, MDMA, MPA, FRCSC 613-544-3400 ext 2410 bellivep@kgh.kari.net

Locations
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Paul Belliveau       bellivep@kgh.kari.net   
Sub-Investigator: Abigail D`Sa, MD         
Sub-Investigator: Kanji Nakatsu, PHD         
Sub-Investigator: Graeme Smith, MD         
Principal Investigator: Paul Belliveau, MD         
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Paul J Belliveau, MD Queen's University
  More Information

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT01050712     History of Changes
Other Study ID Numbers: POICO-B
Study First Received: January 14, 2010
Last Updated: October 8, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014