Osmotic therapy for severe subarachnoid hemorrhage patients
Practice of Osmotherapy in Severe SubArachnoid Hemorrhage Patients: Multicenter Observational Study (OSMO-SAH Study)
Xuanwu Hospital, Beijing · NCT05858060
This study is testing whether two different treatments, mannitol and hypertonic saline, can help patients with severe subarachnoid hemorrhage recover and if they work similarly.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05858060 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of two osmotic therapies, 20% mannitol and 10% hypertonic saline, on patients with severe subarachnoid hemorrhage (SAH). Participants will receive treatment based on local expert consensus, and the outcomes of those treated with mannitol will be compared to those treated with hypertonic saline. The study seeks to determine if the outcomes for patients receiving hypertonic saline are comparable to those receiving mannitol. Data will be collected and analyzed to assess the effectiveness of these treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with aneurysmal subarachnoid hemorrhage and classified as Hunt-Hess grade 3 to 5.
Not a fit: Patients with previous cranial decompression surgery, severe organ dysfunction, or serious electrolyte and acid-base balance disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective osmotic therapy for improving outcomes in severe SAH patients.
How similar studies have performed: While the approach of comparing osmotic therapies is not widely tested, similar studies have shown varying outcomes with osmotic treatments in SAH patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* ①age ≥18； ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5级
Exclusion Criteria:
* previous cranial decompression surgery, cerebrospinal fluid leakage or drainage,
* bilateral pupils fixed or dilated,
* hemodynamic instability,
* hemoglobin \< 8g / L,
* serum osmolality \> 320 mOsm / L,
⑥ combined with severe organ dysfunction (cardiac, pulmonary, hepatic, renal and so on);
⑦ serious electrolyte disorders (serum sodium concentration \<125 mmol / L or \>170 mmol / L), and difficult to correct within limited time;
⑧ serious acid-base balance disorders, and difficult to correct within limited time;
⑨ use of mannitol or HSS within previous six hours;
⑩ being pregnant.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital — Beijing, Beijing Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Subarachnoid Hemorrhage, Traumatic, Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome