Recruiting

Clostridial Infection

Sponsor:

Ascension Health

Code:

NCT01630096

Conditions

Clostridium Difficile Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nu-Lytely

Study Details

Brief summary:

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.

Conditions

Clostridium Difficile Colitis

Study ID

NCT01630096

Start date

Jun, 2012

Status verified date

Aug, 2012

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Interventions and Outcome Measures

Arms

active comparator: Nu-Lytely

Bowel prep solution.

no intervention: Control

Standard of care.

Interventions

Nu-Lytely

Bowl prep solution.

Primary outcome measure

  • Length of stay [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

Genesys Regional Medical Center

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Kimberly Barber, PhD

810-606-7724

More Information

Sponsor

Ascension Health

Last update posted

Aug 17, 2012

Last verified

Aug, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ascension Health on 2012-08-17.