NCT01329887

The Effect of Ketanserin on the Microcirculation in Sepsis

Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Frisius Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	ketanserin	ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-04-06
• Last updated: 2014-05-09

Locations

1 site across 1 country: Netherlands