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

Hemolytic Uremic Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561248
• Other study ID #: EHEC-2011-PEG
• Status: Completed
• Phase: N/A
• First received: January 23, 2012
• Last updated: March 21, 2012
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis
• Communicable Diseases
• Escherichia coli Infections
• Hemolytic Uremic Syndrome
• Hemolytic-Uremic Syndrome
• Hemorrhagic Colitis
• Infection
• Intestinal Diseases
• Intestinal Infection Due to E. Coli
• Intestinal Infectious Disease

Intervention

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.

Locations

Country	Name	City	State
Germany	1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Patients will be followed for the duration of hospital stay, an expected average of two weeks	No