Perihabilitación nutricional en veteranos mayores sometidos a cirugía
Perihabilitación nutricional (alta en proteínas) en veteranos mayores sometidos a cirugía
This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are malnourished and at risk of malnutrition. The second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In year 1 of the two-part research study, an observational, prospective study of 75 Veterans preparing for elective surgery will be conducted. The purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. In years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. The purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. Veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. Participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. The study will take place two weeks prior to an elective abdominal or GI surgery and will continue 4 weeks post surgery.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Durham VA Medical Center, Durham, NC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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Elective abdominal surgery
- upper GI
- colorectal
- hepatobiliary
- pancreatic
- intra-abdominal
- Abdominal aortic aneurysm
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Referred to the VA Perioperative Optimization of Senior Health Clinic
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Able to record dietary intake or has a proxy who can record dietary intake
Exclusion Criteria:
- Cognitive impairment
- Unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks
- Living in skilled nursing facility
- No access to telephone
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PeriHab
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. |
Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.
Otros nombres:
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Comparador activo: PoshControl
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. |
provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Periodo de tiempo: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
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Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained. |
day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
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Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
Periodo de tiempo: 30-day post-surgery follow-up (endpoint)
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Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree |
30-day post-surgery follow-up (endpoint)
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Physical Function
Periodo de tiempo: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
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Short physical performance battery - higher scores means a better physical performance (Total score = 0-12) |
Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nutritional Risk Screener-2002
Periodo de tiempo: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Handgrip Strength
Periodo de tiempo: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials. |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Dietary Intake
Periodo de tiempo: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Three day food records will be collected. |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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|
Patient Generated-Subjective Global Assessment
Periodo de tiempo: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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|
Discharge Location
Periodo de tiempo: endpoint (30 days post-surgery)
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determine from medical records |
endpoint (30 days post-surgery)
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Length of Stay
Periodo de tiempo: endpoint (30 days post-surgery)
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determine from medical records |
endpoint (30 days post-surgery)
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Emergency Department Readmission
Periodo de tiempo: endpoint (30 days post-surgery)
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Prevalence of emergency department admissions following surgery. |
endpoint (30 days post-surgery)
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Postoperative Complications
Periodo de tiempo: endpoint (30 days post-surgery)
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determine from medical records |
endpoint (30 days post-surgery)
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Albumin, g/dL
Periodo de tiempo: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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A measure of protein in the blood. Lower level may indicate infection or inflammation. |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Hospital Readmission
Periodo de tiempo: endpoint (30 days post-surgery)
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determine from medical records |
endpoint (30 days post-surgery)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kathryn N. Starr, PhD, Durham VA Medical Center, Durham, NC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E2348-W
- IK2RX002348 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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