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Completed

NCT Number: NCT01329887

The Effect of Ketanserin on the Microcirculation in Sepsis

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

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Centre Leeuwarden

Leeuwarden, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • severe sepsis and MFI < 2,5 after resuscitation

Exclusion criteria

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

Treatment and study plan

Ketanserin

Drug

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

Primary outcomes

  1. microcirculation

    Time frame: 2 hours

    achievement of a microvascular flow index >2,9

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 6, 2011
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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