We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Ketanserin on the Microcirculation in Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329887
First Posted: April 6, 2011
Last Update Posted: May 9, 2014
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.
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT01329887


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

Responsible Party: E.C. Boerma, Dr, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01329887     History of Changes
Other Study ID Numbers: TPO 736
First Submitted: April 4, 2011
First Posted: April 6, 2011
Last Update Posted: May 9, 2014
Last Verified: May 2014

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

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