Back to resultsThe Effect of Ketanserin on the Microcirculation in Sepsis
Primary Purpose
Severe Sepsis, Septic Shock
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
ketanserin
Sponsored by
About this trial
This is an interventional treatment trial for Severe Sepsis focused on measuring microcirculation, SDF, ketanserin, severe sepsis
Eligibility Criteria
Inclusion Criteria:
- severe sepsis and MFI < 2,5 after resuscitation
Exclusion Criteria:
- age < 18 year old
- pregnant
- participation other trials prolonged Qt interval
Sites / Locations
- Medical Centre Leeuwarden
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
administration of ketanserin
Arm Description
Outcomes
Primary Outcome Measures
microcirculation
achievement of a microvascular flow index >2,9
Secondary Outcome Measures
ketanserine dosage
obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01329887
Brief Title
The Effect of Ketanserin on the Microcirculation in Sepsis
Official Title
Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Centre Leeuwarden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
microcirculation, SDF, ketanserin, severe sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
administration of ketanserin
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
ketanserin
Intervention Description
ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr
Primary Outcome Measure Information:
Title
microcirculation
Description
achievement of a microvascular flow index >2,9
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
ketanserine dosage
Description
obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
severe sepsis and MFI < 2,5 after resuscitation
Exclusion Criteria:
age < 18 year old
pregnant
participation other trials prolonged Qt interval
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E Boerma, MDPhD
Organizational Affiliation
Medical Centre Leeuwarden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Centre Leeuwarden
City
Leeuwarden
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Effect of Ketanserin on the Microcirculation in Sepsis
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