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Effects of Levosimendan on Microcirculation in Septic Shock

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ClinicalTrials.gov Identifier: NCT00800306
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
University of Roma La Sapienza

December 1, 2008
December 2, 2008
October 15, 2009
November 2007
February 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00800306 on ClinicalTrials.gov Archive Site
  • Acid-base homeostasis [ Time Frame: over a period of 36 hrs from the time of randomization ]
  • Oxygen transport variables [ Time Frame: over a period of 36 hrs from the time of randomization ]
  • Functional capillary density (mm/mm2) (FCD) [ Time Frame: over a period of 36 hrs from the time of randomization ]
  • De Backer score [ Time Frame: over a period of 36 hrs from the time of randomization ]
  • Perfused Vessel Density (PVD) (mm/mm2) [ Time Frame: over a period of 36 hrs from the time of randomization ]
  • Proportion of Perfused vessels (%) (PPV) [ Time Frame: over a period of 36 hrs from the time of randomization ]
-acid-base homeostasis -oxygen transport variables -functional capillary density (mm/mm2) (FCD) -De Backer score -Perfused Vessel Density (PVD) (mm/mm2) -Proportion of Perfused vessels (%) (PPV) [ Time Frame: over a period of 36 hrs from the time of randomization ]
Not Provided
Not Provided
 
Effects of Levosimendan on Microcirculation in Septic Shock
Levosimendan and Inhaled Nitric Oxide for Resuscitating the Microcirculation in Septic Shock. A Randomized Controlled Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Septic Shock
  • Drug: Levosimendan
    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
  • Drug: dobutamine
    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.
  • Experimental: levosimendan
    Intervention: Drug: Levosimendan
  • Active Comparator: Control
    Intervention: Drug: dobutamine
Morelli A, Donati A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Cecchini V, Landoni G, Pelaia P, Pietropaoli P, Van Aken H, Teboul JL, Ince C, Westphal M. Levosimendan for resuscitating the microcirculation in patients with septic shock: a randomized controlled study. Crit Care. 2010;14(6):R232. doi: 10.1186/cc9387. Epub 2010 Dec 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
30
April 2009
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00800306
1102
No
Not Provided
Not Provided
Andrea Morelli, University of Rome "La Sapienza"
University of Roma La Sapienza
Not Provided
Principal Investigator: Andrea Morelli, M.D. University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care
University of Roma La Sapienza
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP