Severe Sepsis, Septic Shock
Conditions
Keywords
microcirculation, SDF, ketanserin, severe sepsis
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.
Interventions
DRUGketanserin
ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr
Sponsors
Frisius Medisch Centrum
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* severe sepsis and MFI \< 2,5 after resuscitation
Exclusion criteria
* age \< 18 year old * pregnant * participation other trials prolonged Qt interval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| microcirculation | 2 hours | achievement of a microvascular flow index \>2,9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ketanserine dosage | 48 hours | obtaining a global indication of the ketanserin dosage needed to achieve a MFI \>2,9 and the incidence of hypotension |
Countries
Netherlands
Outcome results
None listed