The Effect of Ketanserin on the Microcirculation in Sepsis

Septic Shock Clinical Trial

Official title:

Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329887
• Other study ID #: TPO 736
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2011
• Last updated: May 8, 2014
• Start date: March 2011
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe sepsis and MFI < 2,5 after resuscitation

Exclusion Criteria:

• age < 18 year old

• pregnant

• participation other trials prolonged Qt interval

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis

Intervention

Drug:
• ketanserin
ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microcirculation	achievement of a microvascular flow index >2,9	2 hours	No
Secondary	ketanserine dosage	obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension	48 hours	Yes