The Effect of Ketanserin on the Microcirculation in Sepsis

Overview

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

Full Title of Study: “Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2014

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: administration of ketanserin

Clinical Trial Outcome Measures

Primary Measures

  • microcirculation
    • Time Frame: 2 hours
    • achievement of a microvascular flow index >2,9

Secondary Measures

  • ketanserine dosage
    • Time Frame: 48 hours
    • obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension

Participating in This Clinical Trial

Inclusion Criteria

  • severe sepsis and MFI < 2,5 after resuscitation

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical Centre Leeuwarden
  • Provider of Information About this Clinical Study
    • Principal Investigator: E.C. Boerma, Dr – Medical Centre Leeuwarden
  • Overall Official(s)
    • E Boerma, MDPhD, Principal Investigator, Medical Centre Leeuwarden

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