The Effect of Ketanserin on the Microcirculation in Sepsis

NCT ID: NCT01329887

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Severe Sepsis Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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administration of ketanserin

Group Type OTHER

ketanserin

Intervention Type DRUG

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

Interventions

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ketanserin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* severe sepsis and MFI \< 2,5 after resuscitation

Exclusion Criteria

* age \< 18 year old
* pregnant
* participation other trials prolonged Qt interval
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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E.C. Boerma

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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E Boerma, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Frisius Medisch Centrum

Locations

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Medical Centre Leeuwarden

Leeuwarden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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TPO 736

Identifier Type: -

Identifier Source: org_study_id

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