NCT02012946

Brief Summary

This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing major non cardiac surgery, during and after the continuous infusion of levosimendan or dobutamine.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 cardiovascular-diseases

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

December 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

Same day

First QC Date

December 11, 2013

Last Update Submit

December 11, 2013

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • cardiac index

    1-3 days

Study Arms (2)

dobutamine

ACTIVE COMPARATOR

patient receiving dobutamine

Drug: Dobutamine

Levosimendan

ACTIVE COMPARATOR

patient receiving levosimendan

Drug: Levosimendan

Interventions

LevosimendanDRUG

patient receiving levosimendan

Levosimendan
DobutamineDRUG

patient receiving dobutamine

dobutamine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • EF \< 40%, no liver and renal disfynction, chronic cardiopathy

You may not qualify if:

  • acute coronary syndrome, life expectation \<30 days, hemodialysis, ventricular tachycardia/ventricular fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francesco Pugliese

Rome, Rome, 00100, Italy

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

SimendanDobutamine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 17, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2013

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

IT(1)