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Osmotic Therapy for Patients with Severe Subarachnoid Hemorrhage (OSMO-SAH)

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Capital Medical University

Status

Enrolling

Conditions

Subarachnoid Hemorrhage, Traumatic

Study type

Observational

Funder types

Other

Identifiers

NCT05858060
XWNeurosurgicalICU

Details and patient eligibility

About

The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question[s] it aims to answer are:

• whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients?

Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.

Enrollment

124 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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