Comparison of Levosimendan and Dobutamine in cardiac surgery

ISRCTN	ISRCTN54237076
DOI	https://doi.org/10.1186/ISRCTN54237076
Protocol serial number	R-2017-1302-17
Sponsor	National Medical Center 'La Raza'
Funder	National Medical Center 'La Raza'

Submission date: 16/04/2018
Registration date: 17/05/2018
Last edited: 01/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Nayely Garcia Mendez
Scientific

Calle Oriente 158 No. 147, Col. Moctezuma 2da sección
CP. 15530, Deleg. Venustiano Carranza
Mexico City
15530
Mexico

Phone	+52 555 726 56982
Email	ayeyigm@yahoo.com.mx

Study information

Primary study design	Interventional
Study design	Randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN54237076_PIS_v1_14May18.pdf
Scientific title	Hemodynamic effects of Levosimendan in patient undergoing off–pump coronary artery bypass grafting and mitral valve replacement
Study objectives	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(s)	Ethics and Research Committee of Medical National Center “La Raza”, 14/02/2017, ref: 13 CI 14 039 254 COFEPRIS
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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).
Completion date	21/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	24
Key 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
Key exclusion criteria	None
Date of first enrolment	01/08/2017
Date of final enrolment	31/12/2017

Locations

Countries of recruitment

Mexico

Study 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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	Data is stored at the following address by the responsible researchers: http://sirelcis.imss.gob.mx/

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version v1	14/05/2018	01/04/2019	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN54237076_PIS_v1_14May18.pdf: Uploaded 01/04/2019

Editorial Notes

01/04/2019: The participant information sheet has been uploaded.