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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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01561248
Study type Interventional
Source Universitätsklinikum Hamburg-Eppendorf
Contact
Status Completed
Phase N/A
Start date May 2011
Completion date February 2012

See also
  Status Clinical Trial Phase
Terminated NCT00004465 - Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome Phase 3
Terminated NCT00593229 - International Registry and Biorepository for TMA(Thrombotic Microangiopathy) N/A
Recruiting NCT05991245 - French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"
Completed NCT02904863 - Study of 'Vascular Competence' Profile and Endothelial Activation in the Hemolytic Uremic Syndrome in Children and Adults N/A
Recruiting NCT00531089 - Rituximab in Patients With Relapsed or Refractory TTP-HUS Phase 2
Withdrawn NCT01433003 - The Plasma Large-Volume Exchange RCT Phase 3