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

NCT01561248 | Completed

• 1 other identifier: EHEC-2011-PEG
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

EHEC; O104:H4; German; outbreak; polyethylene glycol; Bowel lavage

Outcome Measures

Primary Outcomes (1)

• 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.

  Patients will be followed for the duration of hospital stay, an expected average of two weeks

Secondary Outcomes (1)

• Duration of hospitalisation

  Patients will be followed for the duration of hospital stay, an expected average of two weeks

Study Arms (2)

SOC-treatment

NO INTERVENTION

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.

PEG-Solution, daily bowel lavage

EXPERIMENTAL

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.

Interventions

polyethylene glycol solution for daily bowel lavage. 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.

Also known as: Klean-Prep(Norgine GmBH, Marburg, Germany).

PEG-Solution, daily bowel lavage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Hemolytic-Uremic Syndrome

Condition Hierarchy (Ancestors)

Uremia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia

Study Officials

• Stefan Lüth, M.D.

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

  STUDY DIRECTOR

• Thorben Fründt, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: March 22, 2012
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2012
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

DE (1)