Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Intravenous Exenatide in Patients With Acute Brain Injury

11 de julio de 2018 actualizado por: University of North Carolina, Chapel Hill

Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury

The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

8

Fase

  • Fase 4

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

  • Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina; UNC Medical Center

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:

  • Adults ≥18 years
  • Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay >48 hours
  • Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL
  • Informed consent obtained via proxy

Exclusion Criteria:

  • Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females
  • Type 1 diabetes mellitus
  • History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)
  • Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min
  • Known history of gastroparesis
  • History of surgery on stomach, esophagus or duodenum
  • Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome
  • Concurrent steroid use or planned post-operative steroid use
  • History of organ transplantation
  • Brain death or suspected imminent brain death within the next 72 hours
  • Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg for greater than 15 minutes and refractory to medical intervention
  • Currently enrolled in another investigational drug or device protocol
  • Insulin infusion within 3 hours of study drug administration or confirmed long acting insulin or sulfonylurea use prior to admission within 24 hours of study drug administration
  • Known allergy to exenatide

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: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Exenatida
Droga: Exenatide
50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria
Periodo de tiempo: Over 48 hours from infusion initiation
Feasibility is defined as the percentage of patients 1) experiencing severe hypoglycemia (<40 mg/dL); 2) achieving glucose measurements within goal (110-180 mg/dL); and 3) experiencing nausea requiring discontinuation of exenatide therapy. The pre-specified criteria for determining feasibility includes the following: 1) at least 75% of patients achieving glucose measurements within goal (110-180 mg/dL) and 2) no more than 25% of patients experiencing severe hypoglycemia (<40 mg/dL) or nausea requiring exenatide discontinuation.
Over 48 hours from infusion initiation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Median Glucose Concentration During Exenatide Infusion
Periodo de tiempo: Over 48 hours from infusion initiation
Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Percentage of Glucose Measurements Within Goal Range
Periodo de tiempo: Over 48 hours from infusion initiation
Percentage of glucose measurements within goal range is calculated as the number of glucose measurements within goal range (110-180 mg/dL) for all patients/total number of glucose measurements collected for all patients.
Over 48 hours from infusion initiation
Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)
Periodo de tiempo: Over 48 hours from infusion initiation
Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Glycemic Variability
Periodo de tiempo: Over 48 hours from infusion initiation
Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Median Insulin Use
Periodo de tiempo: Over 48 hours from infusion initiation
Calculated from number of insulin units administered over 48 hours starting at infusion initiation
Over 48 hours from infusion initiation
Percentage of Patients Requiring Rescue Insulin Infusion Protocol
Periodo de tiempo: Over 48 hours from infusion initiation
Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment
Over 48 hours from infusion initiation
Percentage of Hypoglycemic Episodes (<80 mg/dL)
Periodo de tiempo: Over 48 hours from infusion initiation
Percentage of hypoglycemic episodes is calculated as the total number of glucose measurements <80 mg/dL for all patients/total number of glucose measurements collected for all patients.
Over 48 hours from infusion initiation
Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)
Periodo de tiempo: Over 48 hours from infusion initiation
Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Percentage of Patients Experiencing Metabolic Crisis
Periodo de tiempo: Over 48 hours from infusion initiation
Metabolic crisis is defined as cerebral microdialysate glucose concentration <0.7 mmol/L in combination with lactate pyruvate ratio >40. Calculated from hourly microdialysis samples starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Median Daily Intracranial Pressure
Periodo de tiempo: Over 48 hours from infusion initiation
Calculated from hourly measurements starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Median Daily Cerebral Perfusion Pressure
Periodo de tiempo: Over 48 hours from infusion initiation
Calculated from hourly measurements starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Percentage of Hypotensive Episodes (SBP<100 mmHg)
Periodo de tiempo: Over 48 hours from infusion initiation
Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.
Over 48 hours from infusion initiation
Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)
Periodo de tiempo: Over 48 hours from infusion initiation
Calculated from blood pressure measurements starting at infusion initiation over 48 hours
Over 48 hours from infusion initiation
Correlation of Exenatide Concentrations With Creatinine Clearance
Periodo de tiempo: Over 48 hours from infusion initiation
Spearman's correlation coefficient calculated from exenatide concentrations and urine creatinine measurements collected for all patients during the study period. A correlation coefficient is a numerical measure of some type of correlation, meaning a statistical relationship between two variables. Spearman's correlation coefficient assumes values in the range from -1 to +1, where +1 indicates the strongest possible agreement and -1 the strongest possible disagreement.
Over 48 hours from infusion initiation
Exenatide Elimination Rate Constant After Discontinuation of Infusion
Periodo de tiempo: 24 hours
24 hours
Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion
Periodo de tiempo: 24 hours
24 hours
Median Intensive Care Unit Length of Stay
Periodo de tiempo: From enrollment to 30 days post study drug discontinuation
Defined as the number of days admitted to the Intensive Care Unit
From enrollment to 30 days post study drug discontinuation
Median Hospital Length of Stay
Periodo de tiempo: From enrollment to 30 days post study drug discontinuation
Defined as the number of days admitted to the hospital
From enrollment to 30 days post study drug discontinuation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of North Carolina, Chapel Hill

Colaboradores

AstraZeneca
Medtronic

Investigadores

  • Investigador principal: Nicole R. Pinelli, PharmD, University of North Carolina, Chapel Hill

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

1 de agosto de 2015

Finalización primaria (Actual)

1 de agosto de 2017

Finalización del estudio (Actual)

1 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

6 de febrero de 2014

Primero enviado que cumplió con los criterios de control de calidad

6 de febrero de 2014

Publicado por primera vez (Estimar)

10 de febrero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de julio de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

11 de julio de 2018

Última verificación

1 de septiembre de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 13-1391
  • Astra Zeneca Pharmaceuticals (Otro número de subvención/financiamiento: D5550L00025/ISSEXEN0038)
  • Medtronic MiniMed, Inc (Otro número de subvención/financiamiento: NERP14-008)

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. .

Ensayos clínicos sobre Lesiones Cerebrales

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Brazil

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir