Recruiting
Phase 2
Phase 3

Intestinal Lavage

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT02466698

Conditions

Clostridium Difficile

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intestinal Lavage

Vancomycin

PEG

Metronidazole

Study Details

Brief summary:

Clostridium Difficile infections (CDIs) are treated initially with antibiotic therapy and supportive care, with surgical intervention reserved for patients with significant systemic toxicity or perforation. Severe CDI may be refractory to medical management and require surgical intervention, carrying a mortality of approximately 40%.

Mortality associated with CDI increases significantly as the severity of the infection increases. In patients failing medical management, earlier operation is associated with decreased mortality. However, the lack of validated tools to predict the necessity for surgical intervention, combined with the significant morbidity associated with total colectomy significantly reduces the likelihood of patients receiving early surgical intervention. The purpose of the proposed study is to assess the addition of intestinal PEG lavage via nasojejunal tube to usual care in the treatment of adult patients with severe CDI who have no immediate indication for surgical intervention.

Conditions

Clostridium Difficile

Study ID

NCT02466698

Start date

Aug, 2016

Status verified date

Aug, 2018

Completion date

Aug, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (>= 18 years) inpatients at LHSC with symptomatic CDI (diarrhea or colonic ileus)
  • CDI confirmed by standard hospital microbiology lab testing
  • Patients must meet criteria for severe CDI, defined as either: white blood cell > 15,000 or Serum Creatinine > 1.5 times the pre-morbid level
  • Patients must have at least one additional risk factor for severity:

i. Fever >38.5 (if no other source of fever suspected) ii. Vasopressor requirement iii. Mechanical ventilation requirement iv. Serum lactate >5 mmol/L v. Colonic distension (>6cm transverse colon diameter on abdominal Xray or CT) vi. Colonic wall thickening, on abdominal Xray or CT, as reported by radiology. vii. Calculated ATLAS score ≥ 4

Exclusion Criteria:

  • The patient is deemed to have an immediate indication for surgery related to the diagnosis of CDI by the on call General Surgery service.
  • Pre-existing bowel discontinuity (e.g. ileostomy).
  • General Surgery service or most responsible care team deem the patient to have a contraindication to nasojejunal tube or fecal management system
  • Patients anticipated to be intolerant of the study regimen (e.g. severe ileus, unable to tolerate oral intake, etc.)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intestinal Lavage

A nasojejunal tube and fecal management system will be inserted. Intestinal lavage with PEG is initiated and increased to a goal rate of 400cc/hour to a total of 8L of PEG. In the absence of an ileus, lavage should be initiated at 200cc/hr. Tolerance is confirmed if the rectal effluent volume is ≥50% of the lavage volume over the first 6 hours and no emesis has developed. If the consulting surgical service suspects a significant ileus, the lavage is initiated at 100cc/hr. If tolerance is confirmed the lavage rate is increased in a stepwise fashion. Antibiotic regimen will consist of Vancomycin 500mg via nasojejunal every 6 hours and Metronidazole 500 mg IV three times daily for 14 days. PEG will be held for 2 hours after administration of Vancomycin.

active comparator: Usual Care

Patients will receive usual care for severe CDI. This includes an antibiotic regimen of Vancomycin 500mg orally every 6 hours and Metronidazole 500mg IV three times daily for 14 days. The usual care group will receive the same antibiotic doses as the experimental arm of the study. For both arms, indications to escalate treatment to surgical intervention will ultimately be based on the clinical assessment by the surgical service. An absolute indication for surgery is perforation. Other indications such as toxic megacolon, worsening peritonitis or biochemical profile lavage are relative indications that vary according to clinician and individual patient characteristics.

Interventions

Intestinal Lavage

A nasojejunal tube and fecal management system will be inserted. Intestinal lavage with PEG is initiated and increased to a goal rate of 400cc/hour to a total of 8L of PEG. In the absence of an ileus, lavage should be initiated at 200cc/hr. Tolerance is confirmed if the rectal effluent volume is ≥50% of the lavage volume over the first 6 hours and no emesis has developed. If the consulting surgical service suspects a significant ileus, the lavage is initiated at 100cc/hr. If tolerance is confirmed the lavage rate is increased in a stepwise fashion. Antibiotic regimen will consist of Vancomycin 500mg via nasojejunal every 6 hours and Metronidazole 500 mg IV three times daily for 14 days. PEG will be held for 2 hours after administration of Vancomycin.

Vancomycin

Patients will receive standard antibiotic treatment for severe CDI. This includes an antibiotic regimen of Vancomycin 500mg orally every 6 hours and Metronidazole 500mg IV three times daily for 14 days. The standard medical care group (active comparator group) will receive the same antibiotic doses as the experimental arm of the study For both arms, indications to escalate treatment to surgical intervention will ultimately be based on the clinical assessment by the surgical service. An absolute indication for surgery is perforation. Other indications such as toxic megacolon, worsening peritonitis or biochemical profile lavage are relative indications that vary according to clinician and individual patient characteristics.

PEG

Polyethylene glycol 3350, 8L in 48 hours, via a nasojejunal tube will be used to facilitate intestinal lavage.

Metronidazole

Patients will receive standard antibiotic treatment for severe CDI. This includes an antibiotic regimen of Vancomycin 500mg orally every 6 hours and Metronidazole 500mg IV three times daily for 14 days. The standard medical care group (active comparator group) will receive the same antibiotic doses as the experimental arm of the study For both arms, indications to escalate treatment to surgical intervention will ultimately be based on the clinical assessment by the surgical service. An absolute indication for surgery is perforation. Other indications such as toxic megacolon, worsening peritonitis or biochemical profile lavage are relative indications that vary according to clinician and individual patient characteristics.

Primary outcome measure

  • Number of eligible participants recruited into the study [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Tina E Mele, MD PhD

519-663-3970tina.mele@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Tina Mele, MD, PhD

519-663-3970tina.mele@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Aug 13, 2018

Last verified

Aug, 2018

Keywords

  • Colectomy
  • Surgical Procedures, Operative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2018-08-13.