Condition category
Circulatory System
Date applied
16/04/2018
Date assigned
17/05/2018
Last edited
14/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
During heart (cardiac) surgery there are varying degrees of short-lived damage to heart tissure. Many protective strategies have been used to decrease this injury and improve strength of cardiac contraction (contractility). Levosimendan is a medication that has anti-ischaemic effects, which means it helps improve blood flow and therefore oxygen supply, and improves myocardial contractility. These properties suggest potential advantages in high – risk cardiac valve surgery patients where cardioprotection would be valuable.

Who can participate?
Adults aged over 18 years undergoing surgery for heart failure

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the drug Levosimendan during the procedure.
Those in the second group receive a different drug called Dobutamine.
All participants have general anaesthesia and undergo blood flow monitoring throughout.

What are the possible benefits and risks of participating?
Participants may benefit from hemodynamic stability during and after surgery. They also help us identify the benefits for other patients.

Where is the study run from?
National Medical Center 'La Raza' (Mexico)

When is the study starting and how long is it expected to run for?
January 2016 to January 2018

Who is funding the study?
National Medical Center 'La Raza' (Mexico)

Who is the main contact?
Dr Nayely Garcia Mendez (Scientific)
ayeyigm@yahoo.com.mx

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nayely Garcia Mendez

ORCID ID

Contact details

Calle Oriente 158 No. 147
Col. Moctezuma 2da sección
CP. 15530
Deleg. Venustiano Carranza
Mexico City
15530
Mexico
+52 555 726 56982
ayeyigm@yahoo.com.mx

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R-2017-1302-17

Study information

Scientific title

Hemodynamic effects of Levosimendan in patient undergoing off–pump coronary artery bypass grafting and mitral valve replacement

Acronym

Study hypothesis

The use of Levosimendan, in patients undergoing off–pump coronary artery bypass grafting and mitral valve replacement has hemodynamic stability compared to Dobutamine.

Ethics approval

Ethics and Research Committee of Medical National Center “La Raza”, 14/02/2017, ref: 13 CI 14 039 254 COFEPRIS

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Heart failure

Intervention

Participants are randomly allocated to group A (intervention) who receive Levosimendan (SIMDAX ®, country of origin Finland) 0.1mg/kg/min during the transanesthetic, postanesthetic and intensive therapy unit.
Those in group B (control) receive Dobutamine 3-8mg/kg/min infusion.
All participants undergo standardised balanced general anaesthesia and invasive monitoring for the measurement of hemodynamic parameters.
At the end of the surgical procedure, the patients are transferred to the Intensive Care Unit.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Heart failure is recorded if CI <2.0 L/minm2 up to 48 hours postoperatively.
2. Low cardiac output defined 2 L/min/m2. Cardiac index is calculated from cardiac output, which is measured using the thermodilution technique via the Swan-Ganz catheter up to 48 hours postoperatively.

Secondary outcome measures

1. Central venous pressure, pulmonary capillary wedge pressure, systemic vascular resistance are measured with a pulmonary artery catheter.
2. Arterial blood pressure is measured via an arterial catheter.
3. Mixed venous oxygen saturation (SV02) is measured by analysis of blood gases.

All the above outcomes are assessed on arrival back in the ICU following surgery (T1) and 48 hours postoperatively (T2).

Overall trial start date

21/01/2016

Overall trial end date

21/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients aged over 18 years
2. Left ventricular ejection fraction ≥=30%.
3. NYHA III-IV.
4. IC ≤ 2.5L
5. ASA II or ASA III

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

None

Recruitment start date

01/08/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Mexico

Trial participating centre

National Medical Center 'La Raza'
Calzada Vallejo Y Paseo de Las Jacarandas S/N La Raza 02990 Ciudad de México
Mexico City
02990
Mexico

Sponsor information

Organisation

National Medical Center 'La Raza'

Sponsor details

Calzada Vallejo Y Paseo de Las Jacarandas S/N
La Raza
02990 Ciudad de México
CDMX
Mexico City
15530
Mexico
57245900
gcareaga3@gmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

National Medical Center 'La Raza'

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
Data is stored at the following address by the responsible researchers: http://sirelcis.imss.gob.mx/

Intention to publish date

01/06/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes