Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis

Not Applicable

Completed

• Conditions: Hemolytic Uremic Syndrome; Hemorrhagic Colitis; Intestinal Infectious Disease; Intestinal Infection Due to E. Coli
• Interventions: Drug: polyethylene glycol solution for daily bowel lavage.

• Registration Number: NCT01561248
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-06
• Study First Submitted: 2012-01-23
• Study Completion: 2012-02
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Study First Posted: 2012-03-22
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-Solution, daily bowel lavage	polyethylene glycol solution for daily bowel lavage.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg; 🇩🇪 Hamburg, Germany