The Effect of Ketanserin on the Microcirculation in Sepsis

This study is currently recruiting participants.
Verified October 2013 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 28, 2013
Last verified: October 2013

April 4, 2011
October 28, 2013
March 2011
March 2014   (final data collection date for primary outcome measure)
microcirculation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
achievement of a microvascular flow index >2,9
Same as current
Complete list of historical versions of study NCT01329887 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
The Effect of Ketanserin on the Microcirculation in Sepsis
Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care

This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
Drug: ketanserin
ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr
administration of ketanserin
Intervention: Drug: ketanserin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • severe sepsis and MFI < 2,5 after resuscitation

Exclusion Criteria:

  • age < 18 year old
  • pregnant
  • participation other trials prolonged Qt interval
Both
18 Years and older
No
Contact: Matty Koopmans, RN matty.koopmans@znb.nl
Netherlands
 
NCT01329887
TPO 736
No
E.C. Boerma, Medical Centre Leeuwarden
Medical Centre Leeuwarden
Not Provided
Principal Investigator: E Boerma, MDPhD Medical Centre Leeuwarden
Medical Centre Leeuwarden
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP