NCT03855579

Brief Summary

To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

February 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

March 6, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

February 24, 2019

Last Update Submit

March 5, 2019

Conditions

Hemodynamics

Keywords

LevosimendanMilrinoneOff-pumpCoronary

Outcome Measures

Primary Outcomes (2)

  • Mean blood pressure

    Intraoperative

  • Consumption of other inotropes

    Intraoperative

Study Arms (2)

Levosimendan

EXPERIMENTAL

Intraoperative infusion of Levosimendan

Drug: Levosimendan

Milrinone

ACTIVE COMPARATOR

Intraoperative infusion of Milrinone

Drug: Milrinone

Interventions

LevosimendanDRUG

Intraoperative infusion of Levosimendan

Levosimendan
MilrinoneDRUG

Intraoperative infusion of Milrinone

Milrinone

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective off-pump coronary artery bypass grafting surgery.
  • ejection fraction \< 50%

You may not qualify if:

  • Patients with severe renal impairment or renal failure.
  • Patients on mechanical support (intra-aortic balloon pump)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

SimendanMilrinone

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmrinoneAminopyridinesAminesPyridines

Central Study Contacts

Hany M. Osman, M.D.

CONTACT

+201002414591hanymeo@aun.edu.eg

Fatma Mohamed, M.D.

CONTACT

fatmanabil2012@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2019

First Posted

February 27, 2019

Study Start

March 6, 2019

Primary Completion

September 10, 2019

Study Completion

September 10, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

EG(1)