The Effect of Ketanserin on the Microcirculation in Sepsis | NCT01329887

Studies
The Effect of Ketanserin on the Microcirculation in Sepsis

NCT01329887

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

May 9, 2014Estimated

Enrollment

10Actual

Phase

Phase 3

Conditions

Severe Sepsis
Septic Shock

Interventions

ketanserin

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Apr 4, 2011

First Submission Date that Met QC Criteria

Apr 5, 2011

First Posted Date

Apr 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2014

Last Update Posted Date

May 9, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
administration of ketanserin	Other		Drug: ketanserin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ketanserin	Drug	ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr	administration of ketanserin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microcirculation	achievement of a microvascular flow index >2,9	2 hours

Secondary Outcomes

Measure	Description	Time Frame
ketanserine dosage	obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

severe sepsis and MFI < 2,5 after resuscitation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
E Boerma, MDPhD	Frisius Medisch Centrum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Centre Leeuwarden		Leeuwarden			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007650	Ketanserin

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D052999	Quinazolinones

Browse Leaves

Not provided

Browse Branches

Not provided