The Effect of Ketanserin on the Microcirculation in Sepsis

Phase 3

Completed

• Conditions: Septic Shock; Severe Sepsis
• Interventions: Drug: ketanserin

• Registration Number: NCT01329887
• Lead Sponsor: Medical Centre Leeuwarden

Brief 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• severe sepsis and MFI < 2,5 after resuscitation

Exclusion Criteria

• age < 18 year old
• pregnant
• participation other trials prolonged Qt interval

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
administration of ketanserin	ketanserin	-

Primary Outcome Measures

Name	Time	Method
microcirculation	2 hours	achievement of a microvascular flow index \>2,9

Secondary Outcome Measures

Name	Time	Method
ketanserine dosage	48 hours	obtaining a global indication of the ketanserin dosage needed to achieve a MFI \>2,9 and the incidence of hypotension

Trial Locations

Locations (1)

Medical Centre Leeuwarden; 🇳🇱 Leeuwarden, Netherlands