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Effects of Levosimendan on Microcirculation in Septic Shock

Primary Purpose

Septic Shock

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Levosimendan

dobutamine

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring sepsis, septic shock, microcirculation, levosimendan, dobutamine, inotropes, inhaled nitric oxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

levosimendan

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT00800306

First Posted

December 1, 2008

Last Updated

October 14, 2009

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT00800306

Brief Title

Effects of Levosimendan on Microcirculation in Septic Shock

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

Keywords

sepsis, septic shock, microcirculation, levosimendan, dobutamine, inotropes, inhaled nitric oxide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

levosimendan

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Levosimendan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

dobutamine

Intervention Description

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 Outcome Measure Information:

Title

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

Time Frame