Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis (EHEC-PEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01561248
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : March 22, 2012
Information provided by (Responsible Party):
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01561248

1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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

Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01561248     History of Changes
Other Study ID Numbers: EHEC-2011-PEG
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
polyethylene glycol
Bowel lavage

Additional relevant MeSH terms:
Communicable Diseases
Hemolytic-Uremic Syndrome
Escherichia coli Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pharmaceutical Solutions