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

NCT ID: NCT01561248

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-02-29

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.

Conditions

Hemolytic Uremic Syndrome; Hemorrhagic Colitis; Intestinal Infectious Disease; Intestinal Infection Due to E. Coli

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

polyethylene glycol solution for daily bowel lavage.

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Klean-Prep(Norgine GmBH, Marburg, Germany).

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Lüth, M.D.

Role: STUDY_DIRECTOR

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

Thorben Fründt, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hamburg, City state of Hamburg, Germany

Countries

Germany

Other Identifiers

EHEC-2011-PEG

Identifier Type: -

Identifier Source: org_study_id