Can a drug that improves blood flow and oxygen supply to the heart improve outcomes during and after heart surgery?

ISRCTN	ISRCTN17397629
DOI	https://doi.org/10.1186/ISRCTN17397629
Secondary identifying numbers	R-2013-3502-48

Submission date: 13/12/2018
Registration date: 24/06/2019
Last edited: 17/01/2020

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 tissue. Many protective strategies have been used to decrease this injury and improve strength of cardiac contraction (contractility). Dexmedetomidine 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 Dexmedetomidine during the procedure. Those in the second group receive a different drug called Esmolol. 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?
General Hospital "Doctor Gaudencio González Garza" of the National Medical Center La Raza (Mexico)

When is the study starting and how long is it expected to run for?
January 2014 to May 2017

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

Who is the main contact?
Dr. Nayely Garcia Mendez (Ph Scientific) ayeyigm@yahoo.com.mx
Dr. Guillermo Careaga (Ph Scientific) gcareaga3@gmail.com

Contact information

Dr Nayely García-Méndez
Scientific

Oriente 158. No. 147 Col Moctezuma 2da. sección. CP. 15530 Delegación Venustiano Carranza. México. Ciudad de México
Ciudad de México
15530
Mexico

ORCID ID	0000-0002-2251-8148
Phone	946431070
Email	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	No participant information sheet available
Scientific title	Esmolol vs dexmedetomidine for attenuation of haemodynamic responses in patients undergoing elective off-pump coronary artery bypass grafting: a randomised controlled trial
Study acronym	N/A
Study objectives	The use of dexmedetomidine in patient undergoing off pump coronary artery bypass grafting they present with haemodynamic stability in comparison with esmolol
Ethics approval(s)	Hospital ethics committee on Medical Center "La Raza" (Comité Local de Investigación y Ética en Investigación en Salud), 14/12/2013, ref. 3502
Health condition(s) or problem(s) studied	Heart failure
Intervention	A controlled clinical study in patients undergoing elective coronary revascularization during off pump coronary artery bypass grafting, under standardized general anesthesia. Randomly received infusions of Esmolol 0.5 mg /kg/1 min (Group E, n=10) or Dexmedetomidine 0.5 cg/kg/hr. (Group DEX, n=10). Randomization was carried out through a random number generator, by means of repetitions divided into 2 treatments, with The R Foundation for Statistical Computing Version 2.15.1 package. The monitored parameters were: invasive blood pressure, oxygen saturation, electrocardiogram, bispectral index for the depth of anesthesia, and central catheter. The hemodynamic data outcome variables of study : heart rate and invasive blood pressure were analyzed at different times: t1) basal, t2) sternotomy, t3) coronary artery bypass and t4) sternal wires during surgery. We have compared analysis of hemodynamic profile, narcotics and muscle relaxant rate, arterial blood gas and fluid were recorded during surgery. All patients underwent balanced general anesthesia with desflurane and invasive monitoring for the measurement of hemodynamic parameters. At the end of the surgical procedure, the patients were transferred to the Intensive Care Unit (ICU).
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 will be assessed using a pulmonary artery catheter at were stratified by quartiles of mean CVP during the first 48 hours after ICU admission. 2. Pulmonary capillary wedge pressure will be assessed using a pulmonary artery catheter. The changes in the pulmonary circulation in 20 cardiac surgery patients undergoing off pump coronary artery bypass grafting. 3. Low systemic vascular resistance during cardiac surgery will be assessed using a pulmonary artery catheter, and vigileo monitor for data outcome variables. 4. Diference in perioperative arterial blood preassure measered by Arterial blood pressure will be assessed using an arterial radial catheter during the first 48 h after ICU admission. 5. Mixed venous oxygen saturation (SVO2) will be assessed by analysis of blood gases by vigileo monitor. 6. Variables of haemodynamics monitoring by Vigileo Monitor EDWARDS LIFESCIENCES, in cardiac surgery patients undergoing off pump coronary artery bypass grafting, moniroring cardiac output, surgical patients requiring continuous invasive monitoring during ICU stay. Start in induction of anaesthesia, sternotomy, grafting of coronary descending, post-revascularization and 48 h after ICU. 7. Laboratory results related to organ dysfunction and the length of ICU admission and hospitalization.
Overall study start date	01/01/2014
Completion date	01/05/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	1. Aged over 18 years 2. Off-pump cardiac surgery 3. Left ventricular ejection fraction ≥40% 4. New York Heart Association classification III-IV 4. IC ≤2.5 L 5. American Society of Anaesthesiologists (ASA) physical status classification II or III
Key exclusion criteria	1. Patients with liver or kidney failure. 2. Patients requiring coronary revascularization with extracorporeal circulation. 3. Candidates for cardiac reoperation. 4. Patients with hemodynamic instability, cardiogenic shock.
Date of first enrolment	01/03/2014
Date of final enrolment	30/04/2017

Locations

Countries of recruitment

Mexico

Study participating centre

General Hospital "Doctor Gaudencio González Garza" of the National Medical Center La Raza

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

Sponsor information

UNIVERSIDAD LA FRONTERA
University/education

Facultad de Medicina - UFRO
Manuel Montt 112 -Of.408 4º piso
Temuco
Tel. 45-25-96-917, ext. 6917
Temuco, Chile
4780000
Chile

Phone	45-25-96-917, ext. 6917
Email	tamara.otzen@ufrontera.cl
Website	https://www.ufro.cl

UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO
University/education

University City
Coyoacán
Mexico City
04510
Mexico

Email	abc@email.com
Website	www.unam.mx

University of La Frontera
Not defined

Website	http://www.ufro.cl/
"ROR"	https://ror.org/04v0snf24

Funders

Funder type

Government

INSTITUTO MEXICANO DEL SEGURO SOCIAL

No information available

Results and Publications

Intention to publish date	30/12/2018
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/

Editorial Notes

17/01/2020: Internal review.