Effects of Levosimendan on Microcirculation in Septic Shock
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00800306|
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : October 15, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: Levosimendan Drug: dobutamine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Levosimendan and Inhaled Nitric Oxide for Resuscitating the Microcirculation in Septic Shock. A Randomized Controlled Trial|
|Study Start Date :||November 2007|
|Primary Completion Date :||February 2008|
|Study Completion Date :||April 2009|
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
|Active Comparator: Control||
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800306
|Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155|
|Rome, Italy, 00161|
|Principal Investigator:||Andrea Morelli, M.D.||University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care|