NCT01329887

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

3.2 years

First QC Date

April 4, 2011

Last Update Submit

May 8, 2014

Conditions

Severe SepsisSeptic Shock

Keywords

microcirculationSDFketanserinsevere sepsis

Outcome Measures

Primary Outcomes (1)

  • microcirculation

    achievement of a microvascular flow index \>2,9

    2 hours

Secondary Outcomes (1)

  • ketanserine dosage

    48 hours

Study Arms (1)

administration of ketanserin

OTHER
Drug: ketanserin

Interventions

ketanserinDRUG

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

administration of ketanserin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • age \< 18 year old
  • pregnant
  • participation other trials prolonged Qt interval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, Netherlands

Location

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Ketanserin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinazolinonesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • E Boerma, MDPhD

    Frisius Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 6, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

NL(1)