Trials / Completed
CompletedNCT01561248
Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis
Repetitive Intestinal Lavage Using Polyethylene Glycol Solution in Patients With EHEC O104:H4 Infection During the German 2011 Outbreak for Prevention of Severe Thrombocytopenia With Subsequently Following Therapeutic Plasmapheresis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.
Detailed description
During the 2011 German EHEC O104:H4 outbreak, centered in the area of Hamburg, 33 patients with EHEC associated hemorrhagic colitis were admitted to the first Department of Medicine of the Hamburg University medical centre. The first 12 patients were treated symptomatically and received intravenous rehydration up to three liters daily. Prompted by a good clinical response after whole bowel irrigation with polyethylene glycol-solution (PEG)in patient 13 all subsequent admitted patients (n=21) were treated with PEG-solution ( 2 liters on admission followed by one liter per day during the clinical course). During the hospital course blood work was obtained every day and patients were examined for clinical symptoms. Thrombocytopenia below 100.000/microliter was defined as a threshold for initiating therapeutic plasmapheresis to prevent the onset of hemolytic syndrome on an early stage.
Conditions
- Hemolytic Uremic Syndrome
- Hemorrhagic Colitis
- Intestinal Infectious Disease
- Intestinal Infection Due to E. Coli
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | polyethylene glycol solution for daily bowel lavage. | At admission,patients with severe EHEC infection received two liters of orally administered electrolytes- balanced polyethylene glycol solution for bowel lavage. Treatment was continued with one liter of polyethylene glycol solution daily for repetitive intestinal lavage during the clinical course. |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2011-06-01
- Completion
- 2012-02-01
- First posted
- 2012-03-22
- Last updated
- 2012-03-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01561248. Inclusion in this directory is not an endorsement.