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

Information source: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemolytic Uremic Syndrome; Hemorrhagic Colitis; Intestinal Infectious Disease; Intestinal Infection Due to E. Coli

Intervention: polyethylene glycol solution for daily bowel lavage. (Drug)

Phase: N/A

Status: Completed

Sponsored by: Universitätsklinikum Hamburg-Eppendorf

Official(s) and/or principal investigator(s):
Stefan Lüth, M.D., Study Director, Affiliation: Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
Thorben Fründt, M.D., Principal Investigator, Affiliation: Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Thrombocytopenia (Defined as platlet count below 100.000/microliter)

Secondary outcome: Duration of hospitalisation

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Hamburg 20246, Germany
Additional Information

Starting date: May 2011
Last updated: March 21, 2012

Page last updated: August 23, 2015

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