drugset / Trial / NCT00800306

Effects of Levosimendan on Microcirculation in Septic Shock

NCT00800306 ↗

Phase 2 Completed 40 enrolled University of Roma La Sapienza
RandomizedParallel-groupTriple-blindTreatment

Summary

The present study was conducted as a prospective, randomized, controlled study to: * investigate the effects of a combination of levosimendan and inhaled nitric oxide on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock; * test the hypothesis that levosimendan plus inhaled nitric oxide may be effective in restoring microvascular function in septic shock.

Timeline

Start
2007-11
Primary completion
2008-02
Completion
2009-04

Outcome

Met primary endpoint

paper MFIs 2.9 (2.9; 3.0) vs. 2.7 (2.3; 2.8); P < .001 PMID 21182783 ↗

paper Microcirculatory flow indices of small and medium vessels increased over time and were significantly higher in the levosimendan group as compared to the control group PMID 21182783 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dobutamine Small molecule 5 ug/kg Intravenous
Subject Levosimendan Other / unclassified 0.2 ug/kg Intravenous