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
See additional files
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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN54237076_PIS_v1_14May18.pdf Uploaded 01/04/2019