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The Effect of Ketanserin on the Microcirculation in Sepsis

This study is currently recruiting participants.
Verified October 2012 by Medical Centre Leeuwarden
Sponsor:
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01329887
First received: April 4, 2011
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • microcirculation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    achievement of a microvascular flow index >2,9


Secondary Outcome Measures:
  • ketanserine dosage [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension


Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329887

Contacts
Contact: Matty Koopmans, RN matty.koopmans@znb.nl

Locations
Netherlands
Medical Centre Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Matty Koopmans, RN         matty.koopmans@znb.nl    
Principal Investigator: N Vellinga, MD            
Sponsors and Collaborators
Medical Centre Leeuwarden
Investigators
Principal Investigator: E Boerma, MDPhD Medical Centre Leeuwarden
  More Information

No publications provided

Responsible Party: E.C. Boerma, Dr, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01329887     History of Changes
Other Study ID Numbers: TPO 736
Study First Received: April 4, 2011
Last Updated: October 31, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Centre Leeuwarden:
microcirculation
SDF
ketanserin
severe sepsis

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

ClinicalTrials.gov processed this record on May 16, 2013