The ARISE Trial Compares Whether Giving Routine Steroid Replacement or Using Targeted Blood Tests to Guide Replacement Better Protects Certain Patients From Adrenal Insufficiency After the Removal of a Diseased Adrenal Gland. (ARISE)
Adrenalectomy Recovery and Sustained Insufficiency After Steroid Exposure (ARISE): A Randomised Controlled Trial
Adrenalectomy is an operation to remove one of the adrenal glands. It is commonly performed to treat adrenal tumours or conditions that cause excess hormone production. The adrenal glands produce important hormones, including cortisol and aldosterone, which help regulate blood pressure, metabolism and the body's response to stress.
After adrenalectomy, some patients may develop adrenal insufficiency, a condition in which the body does not produce enough of these essential hormones. In severe cases, this can lead to an Addisonian (adrenal) crisis, a life-threatening emergency that can cause shock, organ failure and death if not treated promptly.
The risk of adrenal insufficiency after surgery depends largely on cortisol levels before the operation. In patients with Cushing's syndrome, where there is excessive cortisol production, the risk of adrenal insufficiency after adrenalectomy is almost 100%. For this reason, these patients routinely receive steroid replacement treatment after surgery to replace missing hormones and prevent adrenal crisis.
For other patients undergoing adrenalectomy, the best management approach is less clear. Patients with mild autonomous cortisol secretion (MACS) have a moderate risk of adrenal insufficiency - around 50-65%. Patients with normal cortisol secretion (NCS) may also develop adrenal insufficiency because one adrenal gland has been removed, occurring in around 20-37% of cases.
International medical guidelines currently disagree on how best to manage these patients after surgery. Some recommend measuring cortisol levels the morning after surgery and treating only if levels are low, while others recommend giving steroid treatment to all patients with mild cortisol excess. There is currently no clear guidance for patients with normal cortisol secretion.
This study will compare these management strategies to determine which approach best reduces the risk of adrenal insufficiency after adrenalectomy. The study will be conducted at King's College Hospital and will run for approximately two years.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Recommended for adrenalectomy following adrenal multidisciplinary discussion
- ≥18 years old
- Ability to consent
Exclusion Criteria:
- Overt Cushing's syndrome
- Pregnancy
- Pre-existing confirmed adrenal insufficiency
- Pre-existing steroid therapy (including high dose steroid inhalers)
- History of adrenalectomy
- Bilateral disease as assessed radiologically and clinically
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Empirical Steroid Replacement (Standard Care)
Participants receive routine, empirical steroid replacement therapy following adrenalectomy regardless of post-operative cortisol levels.
This follows the current King's College Hospital standard of care and European Society of Endocrinology / ENSAT guidance.
|
Routine administration of Hydrocortisone (e.g., 50mg-100mg IV followed by oral tapering doses) starting immediately post-adrenalectomy even in presence of normal >300nmol/L cortisol reading on post-operative day 1.
|
|
Experimental: Targeted Replacement (Intervention)
Participants receive targeted steroid replacement based on biochemical assessment (Post-Operative Day 1 cortisol levels).
Participants with normal cortisol levels do not receive steroid replacement.
This follows American Association of Endocrine Surgeons guidelines.
|
Administration of Hydrocortisone is withheld and the patient is monitored if Post-Operative Day 1 (POD1) serum cortisol level is >300nmol/L and patient is asymptomatic.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Sustained Adrenal Insufficiency at 3 Months
Periodo de tiempo: 3 months post-adrenalectomy
|
The proportion of patients who fail a biochemical assessment of adrenal function.
Adrenal insufficiency is defined as a peak cortisol level <420 nmol/L following a 250 µg Short Synacthen Test (SST)
|
3 months post-adrenalectomy
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRAS 368153
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.
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