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The Effect of Ketanserin on the Microcirculation in Sepsis

This study has been completed.
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden Identifier:
First received: April 4, 2011
Last updated: May 8, 2014
Last verified: May 2014
This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.

Condition Intervention Phase
Severe Sepsis Septic Shock Drug: ketanserin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by E.C. Boerma, Medical Centre Leeuwarden:

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

Secondary Outcome 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

Enrollment: 10
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
administration of ketanserin Drug: ketanserin
ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01329887

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

Responsible Party: E.C. Boerma, Dr, Medical Centre Leeuwarden Identifier: NCT01329887     History of Changes
Other Study ID Numbers: TPO 736
Study First Received: April 4, 2011
Last Updated: May 8, 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 processed this record on September 21, 2017