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Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05858060
Collaborator
(none)
124
Enrollment
1
Location
10
Anticipated Duration (Months)
12.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    124 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage: a Prospective, Multicenter, Observational Study
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. modified Rankin score [1 day of discharge]

      The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead.

    2. modified Rankin score [6 months]

      The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • ①age ≥18； ②CT confirmed subarachnoid hemorrhage; ③Hunt-Hess 3-5级
    Exclusion Criteria:
    • previous decompressive craniectomy, a leakage or a drainage of cerebrospinal fluid, bilateral fixed and dilated pupils, unstable hemodynamic conditions, oliguric renal failure, hemoglobin < 8g/L, serum osmolality> 320 mOsm/L, combined with serious dysfunction of organs such as heart, lung, liver, and kidney; combined with severe electrolyte disturbances (especially serum sodium concentration <125 mmol/L or >170 mmol/L) and blood gas dysfunction, which are difficult to correct in a short time；use of hypertonic treatment within 6h; pregnant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xuanwu Hospital Beijing Beijing China 100053

    Sponsors and Collaborators

    • Xuanwu Hospital, Beijing

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lidan Jiang, Principal Investigator, Xuanwu Hospital, Beijing
    ClinicalTrials.gov Identifier:
    NCT05858060
    Other Study ID Numbers:
    • XWNeurosurgicalICU
    First Posted:
    May 15, 2023
    Last Update Posted:
    May 15, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lidan Jiang, Principal Investigator, Xuanwu Hospital, Beijing
    Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome
    Additional relevant MeSH terms:
    Subarachnoid Hemorrhage
    Subarachnoid Hemorrhage, Traumatic
    Hemorrhage

    Study Results

    No Results Posted as of May 15, 2023