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Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe (COLITIS)

This study is currently recruiting participants.
Verified August 2012 by Genesys Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Mark Vance, Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01630096
First received: June 21, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

Once the lab test is positive for c. diff, the investigators will order the patient to have PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for 500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as well. The investigators will plan to check c. diff tests daily to see when they become negative. The investigators will perform chart audit/review to track mortality, the length of stay, ICU days, surgical intervention, and APACHE scores (assessment of disease severity). Chart audit will be used to collect data on their diet and how they feel using a visual analog scale (collected by nursing staff daily as a standard procedure; see attached pain scale). Using chart audit, the investigators will record whether the patient is immunocompromised or not.


Condition Intervention Phase
Clostridium Difficile Colitis
 Drug: Nu-Lytely
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: COLITIS: Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe

Further study details as provided by Genesys Regional Medical Center:

Primary Outcome Measures:
  • Length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Days


Secondary Outcome Measures:
  • Need for surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Did the subject have an operation, if so what was it (colectomy/illeostomy&lavage).


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nu-Lytely
Bowel prep solution.
 Drug: Nu-Lytely
Bowl prep solution.
Other Names:
  • Polyethylene Glycol 3350
  • PEG 3350
No Intervention: Control
Standard of care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old or older male or female testing positive for c. diff

Exclusion Criteria:

  • Pregnancy Less than 18 yrs of age Those sick enough to require surgery at diagnosis Severe ileus or small bowel obstruction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630096

Locations
United States, Michigan
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Kimberly Barber, PhD     810-606-7724        
Sponsors and Collaborators
Genesys Regional Medical Center
Investigators
Principal Investigator: Mark B. Vance, DO GRMC
  More Information

No publications provided

Responsible Party: Mark Vance, DO, Attending Surgeon, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01630096     History of Changes
Other Study ID Numbers: GRMC 12 0008
Study First Received: June 21, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Clostridium Infections
Colitis
Gram-Positive Bacterial Infections
Bacterial Infections
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013