The Effect of Ketanserin on the Microcirculation in Sepsis

Medical Centre Leeuwarden

Status and phase: Completed; Phase 3

Conditions: Severe Sepsis; Septic Shock

Treatments: Drug: ketanserin

Study type: Interventional

Funder types: Other

Identifiers

NCT01329887

TPO 736

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• severe sepsis and MFI < 2,5 after resuscitation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

administration of ketanserin

Other group

Treatment:

Drug: ketanserin