Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe (COLITIS)
Recruitment status was Recruiting
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.
|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|
- Length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]Days
- 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).
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Nu-Lytely
Bowel prep solution.
Bowl prep solution.
No Intervention: Control
Standard of care.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630096
|United States, Michigan|
|Genesys Regional Medical Center||Recruiting|
|Grand Blanc, Michigan, United States, 48439|
|Contact: Kimberly Barber, PhD 810-606-7724|
|Principal Investigator:||Mark B. Vance, DO||GRMC|