- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02869919
Vitamin D in Critically Ill Patients With Acute Kidney Injury (VID-AKI)
Vitamin D Levels in Critically Ill Patients With Acute Kidney Injury
Descripción general del estudio
Descripción detallada
Vitamin D has an important role in calcium homeostasis and the regulation of bone metabolism. It also appears to play a role in various infectious, immunologic, neurologic, cardiovascular and respiratory disorders. Both, biological and observational studies have identified vitamin D deficiency as a risk factor for adverse outcomes during critical illness. However, administration of high dose vitamin D to a general population of critically ill patients with vitamin D deficiency did not reduce mortality or hospital length of stay. The exception was a pre-defined sub-group of patients with Vitamin D levels in the very low range (<30 nmol/L) where hospital mortality was significantly lower in patients treated with Vitamin D.
Vitamin D Metabolism The majority of vitamin D is produced through the direct action of sunlight on 7-dehydrocholesterol in the skin. The inert Vitamin D3 produced in this manner, together with Vitamin D2 or D3 from dietary sources, require hydroxylation in the liver to 25-hydroxyvitamin D [25(OH)D] which is the main circulating form. Conversion of this still inactive substance to the active form, 1,25-dihydroxyvitamin D [1,25(OH)2D], by the enzyme 1α-hydroxylase occurs primarily, but not exclusively, in the proximal renal tubules. Circulatory phosphorous, parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) play an important regulatory role in this process. FGF23 is a bone derived hormone that inhibits renal tubular absorption of phosphate and reduces circulating 1,25(OH)2D. PTH is a hormone secreted by the parathyroid glands in response to hypocalcaemia. It acts to increase the concentration of calcium through several pathways one of which is the upregulation of 1α-hydroxylase, the enzyme responsible for converting 25(OH)D to 1,25(OH)2D.
The majority of both 25(OH)D and 1,25(OH)2D is bound to Vitamin D Binding Protein (VDBP) in circulation. The nuclear Vitamin D Receptors (VDR) which regulate the transcription and expression of Vitamin D targeted genes are only activated by unbound 1,25(OH)2D, which is less than 1% of total circulating Vitamin D.
Vitamin D in chronic kidney disease In patients with chronic kidney disease (CKD) on chronic dialysis, Vitamin D deficiency is common (>80%), and the supplementation with active Vitamin D preparations is strongly recommended to prevent or ameliorate the effects of hyperparathyroid high-turnover bone disease and to reduce the cardiovascular risk.
Vitamin D in general ICU patients ICUs worldwide have reported Vitamin D deficiency ranging from 60-100%. A randomized controlled trial (RCT) in a general population of critically ill patients with vitamin D deficiency showed that administration of high dose vitamin D did not reduce mortality or hospital length of stay. The exception was a pre-defined sub-group of patients with Vitamin D levels in the very low range (<30 nmol/L) in whom hospital mortality was significantly lower in patients treated with Vitamin D. Another RCT investigated the role of 2 different doses of cholecalciferol in 50 critically ill adults with the systemic inflammatory response syndrome. The study showed that prior to randomization 56% of patients were classified as Vitamin D deficient. By day 7 after randomization, Vitamin D levels normalized in >60% of patients and PTH levels decreased over the study period.
Vitamin D and AKI AKI is an abrupt deterioration in kidney function which develops over hours or days for a variety of reasons and can range from mild impairment to acute kidney failure. It affects >50% of critically ill patients worldwide and is independently associated with an increased risk of complications, a longer stay in hospital and high risk of dying. AKI survivors have an increased risk of CKD and premature mortality. A recent study also confirmed a significantly increased risk of bone fractures in patients who survived an episode of AKI requiring renal replacement therapy (RRT).
The causal mechanisms behind the morbidity and mortality associated with AKI are still not fully understood but Vitamin D may play an important role.
The hypothesis of this study is that critically ill patients with AKI have significantly lower Vitamin D levels than critically ill patients without AKI.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Greater London
-
London, Greater London, Reino Unido, SE1 7EH
- Guy's & St Thomas Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
age >18 years presence of organ failure
Exclusion Criteria:
Chronic kidney disease stage 3b-5 Renal Transplant Vitamin D deficiency Vitamin D supplementation Hyperparathyroidism Treatment with total parenteral nutrition Life expectancy <48 hours Patients with haemoglobin <70g/L
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Patients with AKI
critically ill patients with acute kidney injury
|
Vitamin D levels
|
Patients without AKI
critically ill patients without acute kidney injury
|
Vitamin D levels
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Vitamin D levels
Periodo de tiempo: up to 28 days
|
up to 28 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
PTH levels
Periodo de tiempo: up to 28 days
|
up to 28 days
|
FGF23 levels
Periodo de tiempo: up to 28 days
|
up to 28 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marlies Ostermann, PhD, Guy's & St Thomas Hospital
Publicaciones y enlaces útiles
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRAS 196968
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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 AKI
-
Selayang HospitalTerminadoLesión renal aguda | Fallo renal agudo | Insuficiencia Renal, Aguda | Condición adquirida en el hospitalMalasia
-
Mayo ClinicTerminadoLesión renal agudaEstados Unidos
-
University of ChicagoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...ReclutamientoBiomarcadores | Lesión renal agudaEstados Unidos
-
University of CalgaryAlberta Health services; University of Alberta; Covenant HealthTerminadoLesión renal agudaCanadá
-
Mayo ClinicAgency for Healthcare Research and Quality (AHRQ)Activo, no reclutandoLesión renal agudaEstados Unidos
-
RWTH Aachen UniversityMünster, University Hospital, Department of Vascular Surgery; Berlin, University...TerminadoEvaluación temprana de AKI después de la reparación de TAAAAlemania
-
Policlinico HospitalReclutamiento
-
National Taiwan University HospitalReclutamientoEnfermedades Renales Crónicas | ElastografíaTaiwán
-
Hospital General Universitario ElcheDesconocido
-
Western Sussex Hospitals NHS TrustUniversity of SouthamptonTerminadoLesión renal agudaReino Unido