Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis (EHEC-PEG)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Intestinal Infectious Disease; Hemorrhagic Colitis; Hemolytic Uremic Syndrome; Intestinal Infection Due to E. Coli

Treatments: Drug: polyethylene glycol solution for daily bowel lavage.

Study type: Interventional

Funder types: Other

Identifiers

NCT01561248

EHEC-2011-PEG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

SOC-treatment

No Intervention group

Description:

Patients with EHEC associated bloody diarrhoea (n=12) receiving standard of care treatment, consisting of intravenous fluids (2-3 liters/daily), analgetics, including paracetamol and metamizol and metoclopramid, if required.

PEG-Solution, daily bowel lavage

Experimental group

Description:

Patients with EHEC associated bloody diarrhoea (n=21)receiving SOC-treatment, consisting of i.v. fluids (2-3 liter/day), analgetics ( paracetamol and metamizol) or metoclopramid and orally administered polyethylene glycol-solution daily during the clinical course.

Treatment:

Drug: polyethylene glycol solution for daily bowel lavage.