Status:
COMPLETED
Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE)
Lead Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Conditions:
High Altitude Cerebral Edema
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief 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 tho...
Detailed Description
The exact mechanisms by which AMS develops remains poorly understood. Interestingly, brain and spinal cord swelling due to low oxygen levels can also occur in the period following surgery to treat tho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03341676
Start Date
January 14 2019
End Date
August 31 2023
Last Update
June 18 2024
Active Locations (1)
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1
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom, CV2 2DX