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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College Hospital NHS Trust

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recommended for adrenalectomy following adrenal multidisciplinary discussion

≥18 years old

Ability to consent

Disqualifiers

Overt Cushing's syndrome

Pregnancy

Pre-existing confirmed adrenal insufficiency

Pre-existing steroid therapy (including high dose steroid inhalers)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empirical Hydrocortisone Protocol

    Drug

    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.

  • Targeted Treatment Protocol

    Drug

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Empirical Steroid Replacement (Standard Care)Active comparator 1 intervention
Group B: Targeted Replacement (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Sustained Adrenal Insufficiency at 3 Months

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)

Time frame
3 months post-adrenalectomy

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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