Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery (PRECISE)
20 de noviembre de 2019 actualizado por: Meshalkin Research Institute of Pathology of Circulation
Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery. A Pilot, Randomized Controlled Study
This pilot randomized-controlled study will determine the feasibility of large study comparing individualized versus standard blood pressure (BP) management in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB).
Our hypothesis is that maintaining higher BP levels based on preoperative measurements will reduce the incidence of major complications (composite outcome).
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Descripción detallada
Adequate hemodynamic control is a cornerstone in management in patients undergoing different types of surgery. Among all perioperative risk factors, the association between perioperative hypotension and adverse clinical outcomes in noncardiac and cardiac surgery patients is well defined.
Numerous factors are responsible for development of perioperative hypotension. They include but not limited to perioperative use of renin-angiotensin-aldosterone system and calcium channel blockers, hypovolemia, hemodilution, bleeding and inflammatory response syndrome.
To date, several evidence has been accumulated indicating that intraoperational hypertension can be hazardous.
It was shown that even short durations (1 to 5 min) of an intraoperative mean arterial pressure < 55 mmHg were associated with myocardial injuries and acute kidney injury (AKI).
Results of recent large retrospective cohort study conducted in adult patients who underwent cardiac surgery requiring CPB showed that postoperative stroke was strongly associated with sustained mean arterial pressure of less than 64 mmHg during cardiopulmonary bypass.
In patients undergoing CABG the overall incidence of combined cardiac and neurologic complications was significantly lower in the group where MAP during CPB was relatively high (80-110 mmHg) than in the low pressure group (MAP 50-60 mmHg) (p = 0.026). For each of the individual outcomes the trend favored the high pressure group.
Therefore, MAP may be an important intraoperative therapeutic hemodynamic target to reduce the incidence of complications in patients undergoing CPB.
Tipo de estudio
Intervencionista
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Novosibirsk, Federación Rusa, 630055
- Meshalkin Research Institute of Pathology of Circulation
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- ≥18 years old
- Signed informed consent
- Elective cardiac surgery under CPB (CABG or valve surgery)
Exclusion Criteria:
- Unstable Coronary Artery Disease: Recent (< 6 weeks) myocardial infarction, unstable angina, severe (> 70%) left main coronary artery stenosis
- Uncontrolled hypertension preoperatively (SBP > 160 mm Hg)
- Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or intraaortic balloon pumping, preoperative severe acute renal failure (anuria or oliguria <10ml/hr)
- Planned surgery on aorta
- Emergency surgery
- Pregnancy
- Current enrollment into another randomized controlled trial (in the last 30 days)
- Previous enrollment and randomization into current study
- Glomerular filtration rate ≤59 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Individualized BP group
Individualized intraoperative BP management
|
In the treatment group, the nurse will measure resting blood pressure three times in the ward one day before surgery (after a 5-min rest while lying supine). Average measurement will be used to calculate mean arterial pressure (MAP). Before and after CPB patients will receive continuous infusion of norepinephrine to maintain MAP within ± 10% of patients resting MAP. If targeted MAP during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will used. After CPB, the choice of vasopressors/inotropes to maintain predefined MAP will be left on attending anesthesiologists based on patient status. |
|
Comparador de placebos: Standard treatment group
Standard intraoperative BP management
|
Standard treatment strategy will be used aiming to maintain pre-bypass and post-bypass MAP at 65-75 mm Hg.
MAP during CPB will be maintained at 50-60 mm Hg.
If MAP of 50-60 mm Hg during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will be started.
No vasodilators will be used if MAP will exceed predefined range.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Compliance with the protocol
Periodo de tiempo: Operative day 1
|
Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients.
|
Operative day 1
|
|
Successful recruitment rate
Periodo de tiempo: 12 month
|
Successful recruitment rate will be defined as recruitment of 2 patients per week.
|
12 month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative creatinine concentration
Periodo de tiempo: 3 days after surgery
|
Plasma creatinine level will be measured daily during 3 postoperative days.
|
3 days after surgery
|
|
Postoperative cardiac troponin I level
Periodo de tiempo: 12 hours after surgery
|
Cardiac troponin I level wil be measured in the time frame from 6 to 12 hours postoperatively.
|
12 hours after surgery
|
|
Intraoperative blood pressure
Periodo de tiempo: Operative day 1
|
Intraoperative blood pressure (mean, systolic and diastolic) will be registered every 5 minutes intraoperatively using invasive blood pressure monitoring system.
|
Operative day 1
|
|
Rate of postoperative complications
Periodo de tiempo: 30 days after surgery
|
Postoperative complications (myocardial infarction, atrial fibrillation, stroke, delirium, need for renal replacement therapy, infection, reexploration for bleeding) will be defined according to standard European Society of Anaesthesiology/European Society of Intensive Care Medicine definitions where possible.
|
30 days after surgery
|
|
Postoperative blood loss
Periodo de tiempo: Postoperative day 1
|
Drainage volume (ml/kg) will be measured in the next morning after surgery.
|
Postoperative day 1
|
|
Daily Sequential Organ Failure Assessment (SOFA) score
Periodo de tiempo: 30 days after surgery
|
Organ failure will be assessed by using Sequential Organ Failure Assessment (SOFA) score which will be recorded daily until patient discharge from the ICU.
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.
Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure).
The score ranges from 0 to 24 points (the higher the score, the higher the mortality).
|
30 days after surgery
|
|
Peak concentration of lactate during CPB and up to 24 hours after surgery
Periodo de tiempo: Postoperative day 1
|
Lactate values (mmol/l) will be measured every 6 hours during the first 24 postoperative hours.
|
Postoperative day 1
|
|
Oxygen delivery during CPB
Periodo de tiempo: Operative day 1
|
Oxygen delivery during CPB will be calculated according to the standard formula (pump flow x O2 arterial content).
|
Operative day 1
|
|
Cerebral oxygenation (near infrared spectroscopy)
Periodo de tiempo: Operative day1
|
Number of cerebral desaturations will be recorded intraoperatively.
|
Operative day1
|
|
Ventilation > 24 hours
Periodo de tiempo: 30 days after surgery
|
Number of patients with duration of ventilation more than 24 h.
|
30 days after surgery
|
|
Duration of ICU stay and hospitalization
Periodo de tiempo: 30 days after surgery
|
Number of postoperative days spent in the ICU and in the hospital will be counted.
|
30 days after surgery
|
|
30-day all-cause mortality
Periodo de tiempo: 30 days after surgery
|
Number of patients who will die within 30-day after surgery from any cause
|
30 days after surgery
|
|
Need for blood transfusions
Periodo de tiempo: 30 days after surgery
|
Number of patients who will need transfusions of any blood products (RBC, fresh frozen plasma, platelets, cryoprecipitate).
|
30 days after surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Vladimir Lomivorotov, MD, PhD, Meshalkin Research Institute of Pathology of Circulation
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298. Erratum In: Anesthesiology. 2019 Feb;130(2):360.
- Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
- Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
- Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018 Jun;44(6):811-822. doi: 10.1007/s00134-018-5224-7. Epub 2018 Jun 4.
- Gold JP, Charlson ME, Williams-Russo P, Szatrowski TP, Peterson JC, Pirraglia PA, Hartman GS, Yao FS, Hollenberg JP, Barbut D, et al. Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg. 1995 Nov;110(5):1302-11; discussion 1311-4. doi: 10.1016/S0022-5223(95)70053-6.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de enero de 2019
Finalización primaria (Anticipado)
10 de marzo de 2020
Finalización del estudio (Anticipado)
10 de abril de 2020
Fechas de registro del estudio
Enviado por primera vez
3 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
21 de diciembre de 2018
Publicado por primera vez (Actual)
24 de diciembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
20 de noviembre de 2019
Última verificación
1 de noviembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 19
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .