Hemolytic Uremic Syndrome Clinical Trial
— EHEC-PEGOfficial 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
Verified date | March 2012 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | February 2012 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | 1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thrombocytopenia (Defined as platlet count below 100.000/microliter) | 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. |
Patients will be followed for the duration of hospital stay, an expected average of two weeks | Yes |
Secondary | Duration of hospitalisation | Secondary outcome in this study was the duration of hospitalisation in the two groups. Duration of hospitalisation was assessed by reviewing the case notes. | Patients will be followed for the duration of hospital stay, an expected average of two weeks | No |
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