NCT00800306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

October 15, 2009

Status Verified

October 1, 2009

Enrollment Period

3 months

First QC Date

December 1, 2008

Last Update Submit

October 14, 2009

Conditions

Septic Shock

Keywords

sepsisseptic shockmicrocirculationlevosimendandobutamineinotropesinhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

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

    over a period of 36 hrs from the time of randomization

Secondary Outcomes (6)

  • Acid-base homeostasis

    over a period of 36 hrs from the time of randomization

  • Oxygen transport variables

    over a period of 36 hrs from the time of randomization

  • Functional capillary density (mm/mm2) (FCD)

    over a period of 36 hrs from the time of randomization

  • De Backer score

    over a period of 36 hrs from the time of randomization

  • Perfused Vessel Density (PVD) (mm/mm2)

    over a period of 36 hrs from the time of randomization

  • +1 more secondary outcomes

Study Arms (2)

levosimendan

EXPERIMENTAL
Drug: Levosimendan

Control

ACTIVE COMPARATOR
Drug: dobutamine

Interventions

LevosimendanDRUG

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

levosimendan
dobutamineDRUG

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnancy
  • Age \< 18 years
  • Ventricular outflow tract obstruction
  • Mitral valve systolic anterior motion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rome, 00161, Italy

Location

Related Publications (1)

  • 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.

    PMID: 21182783DERIVED

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

SimendanDobutamine

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCatecholaminesAminesPhenethylaminesEthylaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Andrea Morelli, M.D.

    University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2008

First Posted

December 2, 2008

Study Start

November 1, 2007

Primary Completion

February 1, 2008

Study Completion

April 1, 2009

Last Updated

October 15, 2009

Record last verified: 2009-10

Locations

IT(1)