The Effect of Ketanserin on the Microcirculation in Sepsis

Frisius Medisch Centrum10 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Sepsis Septic Shock

Interventions

ketanserinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * severe sepsis and MFI \< 2,5 after resuscitation Exclusion Criteria: * age \< 18 year old * pregnant * participation other trials prolonged Qt interval

Locations (1)

Medical Centre Leeuwarden

Leeuwarden, Netherlands

Outcomes

Primary Outcomes

microcirculation

achievement of a microvascular flow index \>2,9

Time frame: 2 hours

Secondary Outcomes

ketanserine dosage

obtaining a global indication of the ketanserin dosage needed to achieve a MFI \>2,9 and the incidence of hypotension

Time frame: 48 hours

Data from ClinicalTrials.gov

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