Hemolytic Uremic Syndrome, Hemorrhagic Colitis, Intestinal Infection Due to E. Coli, Intestinal Infectious Disease
Conditions
Keywords
EHEC, O104:H4, German, outbreak, polyethylene glycol, Bowel lavage
Brief 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.
Interventions
DRUGpolyethylene 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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Proven EHEC O104:H4-infection Presence of bloody diarrhoea + at least one of the following serological criteria: * platelet count below 150x10³/ μl but greater than 100x10³/ μl, serum creatine above normal level for age (\> 1.1 -1.3 mg/dl), Lactate dehydrogenase (LDH) \> 300 IU/l, leukocytosis ( \> 12x10³/ μl ) and elevated CRP (\> 5mg/l), hemoglobin \< 13.8 g/dL for male patients or \< 12.1 g/dL for female patients, respectively or decrease in haptoglobin
Exclusion criteria
* Bloody diarrhoea due to others reasons than EHEC O104:H4 infection * Thrombocytopenia \< 100x10³/ μl. * HUS, defined as platelet count below 100x10³/ μl, anaemia or decrease in haptoglobin and serum creatine above normal level for age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombocytopenia (Defined as platlet count below 100.000/microliter) | Patients will be followed for the duration of hospital stay, an expected average of two weeks | Following admission, blood samples were taken every day during the hospital course. When a platelet count below 100.000/microliter was measured, patients were subsequently transfered to the department of nephrology for therapeutic plasmapheresis. As thrombocytopenia is the first abnormal laboratory finding in EHEC infected patients developing HUS, therapeutic plasmapheresis was initiated to prevent onset of mature HUS when thrombocytopenia (defined as mentioned above )was measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalisation | Patients will be followed for the duration of hospital stay, an expected average of two weeks | Secondary outcome in this study was the duration of hospitalisation in the two groups. Duration of hospitalisation was assessed by reviewing the case notes. |
Countries
Germany
Outcome results
None listed