Effects of Levosimendan on Microcirculation in Septic Shock
Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock
Intervention: Levosimendan (Drug); dobutamine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Roma La Sapienza Official(s) and/or principal investigator(s): Andrea Morelli, M.D., Principal Investigator, Affiliation: University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care
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.
Clinical Details
Official title: Levosimendan and Inhaled Nitric Oxide for Resuscitating the Microcirculation in Septic Shock. A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)
Secondary outcome: Acid-base homeostasisOxygen transport variables Functional capillary density (mm/mm2) (FCD) De Backer score Perfused Vessel Density (PVD) (mm/mm2) Proportion of Perfused vessels (%) (PPV)
Detailed description:
40 septic shock patients requiring norepinephrine to maintain mean arterial pressure between
65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an
initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and
75 mmHg and a mixed venous oxygen saturation (SvO2) ≥ 65%, patients will be randomly
allocated to be treated with either a) intravenous administration of levosimendan 0. 2
µg∙kg-1∙min-1 for 24 hrs, b)intravenous administration of dobutamine 5 µg∙kg-1∙min-1 for 36
hrs(control; each n = 20). At the end of the first 24 hrs of the study period, both groups
will receive inhaled nitric oxide at the concentration of 35 ppm for further 12 hrs. In all
patients norepinephrine was titrated to maintain mean arterial pressure between 65 and 75
mmHg. Data from right heart catheterization and sublingual microvascular network will be
obtained just before randomization (baseline) and then after 24 and 36 hours.
The sublingual microvascular network will be studied using the sidestream dark field (SDF)
imaging. The device will be applied on the lateral side of the tongue, in an area
approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent
areas will be recorded on disk using a personal computer. These sequences will be later
analyzed by an investigator blinded to the patient's diagnosis and therapy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of Septic shock
- Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg
despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18
mmHg and central venous pressure = 8-12 mmHg)
Exclusion Criteria:
- Pregnancy
- Age < 18 years
- Ventricular outflow tract obstruction
- Mitral valve systolic anterior motion
Locations and Contacts
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155, Rome 00161, Italy
Additional Information
Starting date: November 2007
Last updated: October 14, 2009
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