The Effect of Ketanserin on the Microcirculation in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329887
Recruitment Status : Completed
First Posted : April 6, 2011
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):
E.C. Boerma, 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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: ketanserin Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care
Study Start Date : March 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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

Primary Outcome Measures :
  1. microcirculation [ Time Frame: 2 hours ]
    achievement of a microvascular flow index >2,9

Secondary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • severe sepsis and MFI < 2,5 after resuscitation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329887

Medical Centre Leeuwarden
Leeuwarden, Netherlands
Sponsors and Collaborators
Medical Centre Leeuwarden
Principal Investigator: E Boerma, MDPhD Medical Centre Leeuwarden

Responsible Party: E.C. Boerma, Dr, Medical Centre Leeuwarden Identifier: NCT01329887     History of Changes
Other Study ID Numbers: TPO 736
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by E.C. Boerma, Medical Centre Leeuwarden:
severe sepsis

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Antihypertensive Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs