Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis (EHEC-PEG)
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|ClinicalTrials.gov Identifier: NCT01561248|
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : March 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hemolytic Uremic Syndrome Hemorrhagic Colitis Intestinal Infectious Disease Intestinal Infection Due to E. Coli||Drug: polyethylene glycol solution for daily bowel lavage.||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2011|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||February 2012|
No Intervention: SOC-treatment
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.
Experimental: PEG-Solution, 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.
Drug: polyethylene glycol solution for daily bowel lavage.
At admission,patients with severe EHEC infection received two liters of orally administered electrolytes- balanced polyethylene glycol solution for bowel lavage. Treatment was continued with one liter of polyethylene glycol solution daily for repetitive intestinal lavage during the clinical course.
Other Name: Klean-Prep(Norgine GmBH, Marburg, Germany).
- Thrombocytopenia (Defined as platlet count below 100.000/microliter) [ Time Frame: 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.
- Duration of hospitalisation [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561248
|1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg|
|Hamburg, Germany, 20246|
|Study Director:||Stefan Lüth, M.D.||Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg|
|Principal Investigator:||Thorben Fründt, M.D.||Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg|