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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01561248
First received: January 23, 2012
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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 Intervention
Hemolytic Uremic Syndrome
Hemorrhagic Colitis
Intestinal Infectious Disease
Intestinal Infection Due to E. Coli
Drug: polyethylene glycol solution for daily bowel lavage.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:
  • Duration of hospitalisation [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of two weeks ] [ Designated as safety issue: No ]
    Secondary outcome in this study was the duration of hospitalisation in the two groups. Duration of hospitalisation was assessed by reviewing the case notes.


Enrollment: 33
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01561248

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

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01561248     History of Changes
Other Study ID Numbers: EHEC-2011-PEG
Study First Received: January 23, 2012
Last Updated: March 21, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
EHEC
O104:H4
German
outbreak
polyethylene glycol
Bowel lavage

Additional relevant MeSH terms:
Colitis
Communicable Diseases
Infection
Hemolytic-Uremic Syndrome
Trematode Infections
Azotemia
Hemolysis
Escherichia coli Infections
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Helminthiasis
Parasitic Diseases
Pathologic Processes
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pharmaceutical Solutions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014