Completado

Goal Directed Therapy for Patients Undergoing Major Vascular Surgery

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%

+ Fluid titrated at the discretion of the attending anesthesiologist

Otro
Quiénes están siendo reclutados

De 18 a 85 años
+7 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional
Inicio del estudio: agosto de 2010
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Manitoba
Última actualización: 11 de noviembre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 2010

Fecha en la que se inscribió al primer participante.

The management and delivery of intravenous fluids during surgical operations is one of the important duties for anesthesiologists. There is a growing body of evidence that fluid overload in surgical patients is associated with decreased wound healing, slower return of gut function, anastomotic breakdown, pulmonary edema and post-operative visual changes. In the United States, abdominal aortic aneurysms are diagnosed in 190,000 people per year, and over 50,000 of those have the aneurysm repaired5. Recent advances in endovascular techniques have allowed many of these patients to forego an open repair. However, because of technical difficulties, many patients still require an open repair. The most common cause of morbidity in these patients is related to post-operative gastrointestinal tract dysfunction. This usually involves an adynamic ileus that the patients develop on the fourth post-operative day. This delays their tolerance of enteral foods and lengthens their hospital stay and hospital costs. It also has the potential of causing more morbidity in that patients may require total parenteral nutrition while awaiting return of bowel function. There are several causes of this gastrointestinal morbidity including direct mechanical trauma to the bowel during surgery and activation of the inflammatory cascade. These factors are unfortunately not modifiable by the team caring for the patient. One factor that is modifiable is the amount and type of intravenous fluids administered to the patient. Typically, anesthesiologists decide on the amount of fluid to administer to patients based on parameters such as heart rate, blood pressure and urine output. These are unfortunately unreliable in determining a patient's volume status, as these parameters can be within the normal range, and a patient might still have inadequate perfusion to their vital organs. Further, clinician's reliance on blood pressure as a target for fluid administration ignores the fact that organs require blood flow as well as pressure to function optimally. Until recently, the only way to measure blood flow was with the insertion of a pulmonary artery catheter. Based on several studies showing a lack of benefit of this invasive procedure, it has fallen out of favor in the non-cardiac arena. Newer monitors of cardiac output that can be attached to a patients arterial catheter (commonly placed for major surgical procedures) offer an alternative method for clinicians to measure cardiac output. One of these monitors, the FloTrac system (Edwards Life Sciences, Irvine CA), utilizes the arterial pulse contour to calculate cardiac output (CO) and the stroke volume variation (SVV) as a monitor of volume status. In patients who are mechanically ventilated there is a phasic variation in CO and stroke volume based on the ventilatory cycle. Large changes in stroke volume during the ventilatory cycle may indicate hypovolemia in patients. The administration of intravenous fluid to these patients results in a decrease in the SVV. Thus, the SVV can be use a volume monitor and used to titrate intravenous therapy. There have been several trials (mostly in colonic resection surgery) that have looked at such goal directed therapy with this and similar devices and have found a decrease in patient morbidity and length of stay. All of these studies have in common the use of a minimally invasive CO monitor and a reliance on colloids as the predominant fluid utilized during the case. The utilization of SVV to determine volume status is a novel approach to fluid management in surgical patients. As stated above, clinicians' historical reliance on pressures (such as as blood pressure and central venous pressure) to estimate intravascular volume status is based on an incomplete understanding on the factors that govern organ blood flow. To this end, the investigators will also assess several parameters during this study in an attempt to ascertain which is the best at predicting fluid responsiveness. Fluid responsiveness is defined as the ability to predict if a given patient will increase their CO to a fluid bolus. To date this has not been looked at in a systematic fashion. There is also evidence to suggest that such goal directed therapy reduces the degree of inflammation that invariably occurs after operations of this magnitude. It is hypothesized that by resuscitating the endothelium more effectively with intravenous fluids that remain in the intravascular space longer, there is less endothelial damage and thus less inflammation.

Patrocinador PrincipalUniversity of Manitoba
Última actualización: 11 de noviembre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 40 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 85 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

2 criterios de inclusión requeridos para participar
American Society of Anesthesiologists physical class I-III patients over the age of 18 years

Presenting for elective open repair of abdominal aortic aneurysms

5 criterios de exclusión impiden participar
Active congestive heart failure

Known or suspected valvular aortic insufficiency

Pre-existing bowel dysfunction

Renal Dysfunction (serum creatinine > 150 μmol/l)

Mostrar Más Criterios

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%

Grupo II

Comparador Activo
Fluid titrated at the discretion of the attending anesthesiologist.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

University of Manitoba

Winnipeg, CanadaAbrir University of Manitoba en Google Maps
Completado1 Centros de Estudio