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NCT05914272
Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
trial testing Osmotic drugs in Stroke in 2,592 participants. Not yet recruiting.
1 January 2027
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 2,592 |
| Start date | 1 July 2023 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 January 2027 |
| Sites | 19 locations across China |
Drugs / interventions tested
- Osmotic drugs — full drug profile →
Conditions studied
- Stroke — all drugs for Stroke →
Sponsor
Nanfang Hospital, Southern Medical University
Who can join
18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Stroke remains the second leading cause of death worldwide, with 2%-8% of these being large hemispheric infarction (LHI) with an occupying effect and the worst prognosis. Even with medical and surgical treatment, the mortality of LHI with cerebral edema is as high as 20% to 30%. Current guidelines recommend supportive supervision, osmotic drugs, and decompressive hemicraniectomy (DHC) for the treatment of LHI, but not all patients with LHI are suitable for DHC, and not all of them can afford the high cost of DHC. In the real-world, the use of osmotic drugs is more common than DHC. The guideline recommends using mannitol or hypertonic saline to reduce cerebral edema and tissue displacement in patients with cerebral edema. Mannitol is the most widely used and longest-standing osmotic drug, and since 1965, hypertonic saline has been used to treat intracranial hypertension. Most of the previous studies compare the efficacy of DHC over medical therapy or compare the efficacy of mannitol with hypertonic saline, but there is an absence of clinical data on whether osmotic drug therapy can improve the clinical prognosis of patients with large hemispheric infarction at 90 days or even longer. Therefore, the purpose of this study was to investigate the association between the osmotic drug and clinical outcomes in large hemispheric infarction, with the aim of informing clinical decisions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05914272
- Europe PMC full search
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Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05914272 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanfang Hospital, Southern Medical University
- Last refreshed: 22 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05914272.
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