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
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