Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE)

• Status: Suspended
• Trial end date: 2021-09-04
• Target enrollment: 0
• Participant gender: All

Summary

When the brain detects a drop in oxygen levels in the blood (hypoxia) there is a compensatory increase in blood flow. Acute mountain sickness (AMS) is a cluster of symptoms which commonly occur in those ascending to high altitude and experiencing hypoxia due to increased blood flow and then swelling in the brain. Symptoms include headache, nausea, insomnia and fatigue. The exact mechanisms by which AMS develops remains poorly understood. Dexamethasone has been shown to reduce the risk of developing significant brain swelling in other settings. Therefore we hypothesise that administering low dose Dexamethasone could protect against hypoxia induced cerebral and spinal oedema.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Provision of informed consent

• Healthy men and women aged 20-50 years

• Ability to fully understand the requirements of the protocol

• Negative pregnancy

• BMI <30 kg/m2

Exclusion Criteria:

• Recent experience of high altitude: Any subject who has visited high altitudes (defined as 8,000 - 12,000 feet above sea level) within 4 weeks of starting the study.

• Abnormal blood pressure: AHA guidelines state blood pressures ≥140/90 mmHg require medical management. Patients with a blood pressure above these parameters will be excluded.

• Any evidence of systemic infection e.g. respiratory tract infection.

• Any evidence of renal disease (i.e. eGFR <60, as this precludes intravenous contrast required for MRI scan)

• History of Tuberculosis

• History of heart disease

• Conditions including but not limited to: Glaucoma (including family history), ocular herpes simplex (risk of corneal perforation), severe affective disorders (particularly if history of steroid-induced psychosis), epilepsy, peptic ulcer, hypothyroidism, history of steroid myopathy, ulcerative colitis, diverticulitis, recent intestinal anastomoses, thromboembolic disorders or myasthenia gravis.

• Breastfeeding

• Current smoker

• Contraindications for MRI

• Known sensitivity to the study drug and / or it's excipients: History of hypersensitivity to steroids (any preparation).

• Taking pharmaceutical preparations or over the counter medications known to interact with intravenous Dexamethasone.

• Current participation in other interventional research