Comparison of Levosimendan and Dobutamine in cardiac surgery

ISRCTN ISRCTN54237076
DOI https://doi.org/10.1186/ISRCTN54237076
Secondary identifying numbers R-2017-1302-17
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

Study designRandomised controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN54237076_PIS_v1_14May18.pdf
Scientific titleHemodynamic effects of Levosimendan in patient undergoing off–pump coronary artery bypass grafting and mitral valve replacement
Study objectivesThe 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) studiedHeart failure
InterventionParticipants 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 typeProcedure/Surgery
Primary outcome measure1. 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 measures1. 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 study start date21/01/2016
Completion date21/01/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants24
Key inclusion criteria1. 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 criteriaNone
Date of first enrolment01/08/2017
Date of final enrolment31/12/2017

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

Sponsor information

National Medical Center 'La Raza'
Hospital/treatment centre

Calzada Vallejo Y Paseo de Las Jacarandas S/N
La Raza
02990 Ciudad de México
CDMX
Mexico City
15530
Mexico

Phone 57245900
Email gcareaga3@gmail.com
ROR logo "ROR" https://ror.org/004vn8r55

Funders

Funder type

Hospital/treatment centre

National Medical Center 'La Raza'

No information available

Results and Publications

Intention to publish date01/06/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planData 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

Additional files

ISRCTN54237076_PIS_v1_14May18.pdf
Uploaded 01/04/2019

Editorial Notes

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