NCT00093301

Brief Summary

The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2004

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 2004

First QC Date

October 5, 2004

Last Update Submit

June 23, 2005

Conditions

Cardiogenic ShockSeptic Shock

Keywords

ShockLevosimendanInotropesDobutamineHeart failureSepsis

Outcome Measures

Primary Outcomes (1)

  • Resolution of shock state

Secondary Outcomes (1)

  • Change in cardiac functions

Interventions

LevosimendanDRUG
DobutamineDRUG

Eligibility Criteria

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

You may qualify if:

  • Reduced left ventricular systolic function
  • Hypotension
  • Anuria or oligouria

You may not qualify if:

  • Less than 18 years old
  • Pregnant
  • Uncorrected valvular stenosis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Third degree AV block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Nepean Hospital

Penrith, New South Wales, 2750, Australia

RECRUITING

MeSH Terms

Conditions

Shock, CardiogenicShock, SepticShockHeart FailureSepsis

Interventions

SimendanDobutamine

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisInfectionsSystemic Inflammatory Response SyndromeInflammation

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2004

First Posted

October 7, 2004

Study Start

October 1, 2004

Study Completion

April 1, 2006

Last Updated

June 24, 2005

Record last verified: 2004-10

Locations

AU(1)