Skip to main content
OpenTrials
Completed

NCT Number: NCT00800306

Effects of Levosimendan on Microcirculation in Septic Shock

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155

Rome, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levosimendan

Drug

Intravenous administration of Levosimendan 0,2 µg•kg-1•min-1 for 24 hrs followed by the addition of 35 ppm of inhaled nitric oxide

Dobutamine

Drug

Intravenous administration of dobutamine 5 µg•kg-1•min-1 for 36 hrs. At the end of the first 24 hrs drug infusion, inhaled nitric oxide at the concentration of 35 ppm will be added for further 12 hrs.

Primary outcomes

  1. Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)

    Time frame: over a period of 36 hrs from the time of randomization

Secondary outcomes

  1. Acid-base homeostasis

    Time frame: over a period of 36 hrs from the time of randomization

  2. Oxygen transport variables

    Time frame: over a period of 36 hrs from the time of randomization

  3. Functional capillary density (mm/mm2) (FCD)

    Time frame: over a period of 36 hrs from the time of randomization

  4. De Backer score

    Time frame: over a period of 36 hrs from the time of randomization

  5. Perfused Vessel Density (PVD) (mm/mm2)

    Time frame: over a period of 36 hrs from the time of randomization

  6. Proportion of Perfused vessels (%) (PPV)

    Time frame: over a period of 36 hrs from the time of randomization

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Levosimendan and Inhaled Nitric Oxide for Resuscitating the Microcirculation in Septic Shock. A Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 2, 2008
Registry last updated
Oct 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.