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
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
Scientific
Calle Oriente 158 No. 147, Col. Moctezuma 2da sección
CP. 15530, Deleg. Venustiano Carranza
Mexico City
15530
Mexico
| Phone | +52 555 726 56982 |
|---|---|
| ayeyigm@yahoo.com.mx |
Study information
| Study design | Randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 21/01/2016 |
| Completion date | 21/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
La Raza
02990 Ciudad de México
Mexico City
02990
Mexico
Sponsor information
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 |
|---|---|
| gcareaga3@gmail.com | |
"ROR" |
https://ror.org/004vn8r55 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| 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 |
Additional files
- ISRCTN54237076_PIS_v1_14May18.pdf
- Uploaded 01/04/2019
Editorial Notes
01/04/2019: The participant information sheet has been uploaded.
