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

Primary Purpose

Hemolytic Uremic Syndrome, Hemorrhagic Colitis, Intestinal Infectious Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
polyethylene glycol solution for daily bowel lavage.
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemolytic Uremic Syndrome focused on measuring EHEC, O104:H4, German, outbreak, polyethylene glycol, Bowel lavage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

SOC-treatment

PEG-Solution, daily bowel lavage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 23, 2012
Last Updated
March 21, 2012
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01561248
Brief Title
Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis
Acronym
EHEC-PEG
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemolytic Uremic Syndrome, Hemorrhagic Colitis, Intestinal Infectious Disease, Intestinal Infection Due to E. Coli
Keywords
EHEC, O104:H4, German, outbreak, polyethylene glycol, Bowel lavage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOC-treatment
Arm Type
No Intervention
Arm Description
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.
Arm Title
PEG-Solution, daily bowel lavage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol solution for daily bowel lavage.
Other Intervention Name(s)
Klean-Prep(Norgine GmBH, Marburg, Germany).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Thrombocytopenia (Defined as platlet count below 100.000/microliter)
Description
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.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of two weeks
Secondary Outcome Measure Information:
Title
Duration of hospitalisation
Description
Secondary outcome in this study was the duration of hospitalisation in the two groups. Duration of hospitalisation was assessed by reviewing the case notes.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of two weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Lüth, M.D.
Organizational Affiliation
Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thorben Fründt, M.D.
Organizational Affiliation
Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis

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