A Expoloratory Study to evaluate the Efficacy and Safety of Hydrocortisone for the Prevention of Symptomatic Vasospasm after Subarachnoid Hemorrhage.

JRCT ID: jRCTs051230153

Registered date:25/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with subarachnoid hemorrhage due to cerebral aneurysm rupture
• Date of first enrollment: 25/12/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

The protocol treatment is started on the 5th day after the onset of subarachnoid hemorrhage, and treatment is continued until the protocol discontinuation criteria are met on the 15th day.
1. From the 5th day to the 12th day after onset
Hydrocortisone 200 mg/day, 100 mg x 2 times/day, intravenus administration (in 30 minutes)
2. From day 13 to day 15 of onset
Hydrocortisone 100 mg/day, 100 mg x 1 time/day, intravenus administration (in 30 minutes)

Outcome(s)

• Primary Outcome: Occurrence of symptomatic vasospasm within 14 days after subarachnoid hemorrhage

Secondary Outcome

1. Occurrence of asymptomatic cerebral vasospasm
2. Occurrence of delayed cerebral ischemia
3. Prognosis 6 months after onset of subarachnoid hemorrhage (evaluated by modified Rankin Scale score)
4. Changes in serum sodium/potassium levels for 14 days from the onset of subarachnoid hemorrhage
5. Changes in sodium metabolism-related hormones (ACTH, cortisol, AVP, BNP, renin, aldosterone) within 24 hours of onset of subarachnoid hemorrhage and on days 3, 7, and 12 of onset
6. Changes in daily infusion volume, sodium dose, urine volume, and urinary sodium/potassium excretion for 14 days from the onset of subarachnoid hemorrhage
7. Stratified analysis according to the combination therapy
8. Occurrence of complications
Definition of complications: Occurrence of complications (lung disorder, heart disorder, gastrointestinal bleeding, electrolyte disorder, infection) from day 5 to day 15 of subarachnoid hemorrhage onset (during hydrocortisone administration)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 86age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible.
1. Patients aged between 18 and 85 at the time of informed consent
2. Patients with subarachnoid hemorrhage due to cerebral aneurysm rupture
3. Aneurysm neck clipping or coil embolization was performed for ruptured cerebral aneurysm within 24 hours after onset and up to 4 days after onset
4. Patients who have obtained voluntary written consent from the patient and his/her legal representative to participate in this study (However, if the principal investigator or sub-investigator determines that the patient lacks the capacity to consent due to a disorder of consciousness, etc., only a representative legal representative will be allowed to consent.)

Exclude criteria

1. Patients who are not independent in daily life before onset of subarachnoid hemorrhage (modified Rankin Scale score 2 or higher)
2. Patients with the most severe subarachnoid hemorrhage (WFNS Grade V)
3. Patients with severe cardiac dysfunction (heart failure, arrhythmia, etc.) or renal dysfunction
4. Patients with hypersensitivity to drugs such as allergies
5. Pregnant women, possibly pregnant women, or breast-feeding patients
6. Patients who have participated in another clinical trial and are currently recieving therapeutic drugs in that clinical trial
7. Patients who are contraindicated for hydrocortisone administration, patients who have a history of hypersensitivity to the ingredients of this drug, and patients who are receiving desmopressin acetate hydrate (nocturia due to nocturia in men)
8. Patients who have been receiving corticosteroids before the onset of subarachnoid hemorrhage
9. Patients with acute myocardial infarction, bacterial or fungal infections for whom there are no effective antibiotics
10. In addition, patients who are judged to be inappropriate by the doctor in charge of each facility in this clinical study

Related Information

• Primary Sponsor: Uozumi Yoichi
• Secondary Sponsor: Sasayama Takashi