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Clinical Trial Summary

This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.


Clinical Trial Description

This is a pilot study, including 10 ICU patients with severe sepsis with MFI < 2,5 after fulfillment of a strict resuscitation protocol. At the start of the study, a baseline SDF measurement is made, when MFI < 2,5 inclusion in the study is permitted and intravenous ketanserin administration is started and subsequently increased, guided by the effect on sublingual MFI, until a safe maximum dosage is reached. Safety margins for hypotension are defined in the study protocol. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01329887
Study type Interventional
Source Medical Centre Leeuwarden
Contact
Status Completed
Phase Phase 3
Start date March 2011
Completion date May 2014

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