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A study comparing two treatments mannitol with hypertonic saline versus hypertonic saline alone to find which is better and safer in reducing brain pressure in patients with stroke.

Comparative Efficacy and Safety of 3percent Hypertonic Saline Plus Mannitol versus 3percent Hypertonic Saline Alone in Lowering Intracranial Pressure based on Optic Nerve Sheath Diameter in Stroke Patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096522
Enrollment
142
Registered
2025-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteries Health Condition 2: I610- Nontraumatic intracerebral hemorrhage in hemisphere, subcortical Health Condition 3: I612- Nontraumatic intracerebral hemorrhage in hemisphere, unspecified Health Condition 4: I613- Nontraumatic intracerebral hemorrhage in brain stem Health Condition 5: I614- Nontraumatic intracerebral hemorrhage in cerebellum Health Condition 6: I615- Nontraumatic intracerebral hemorrhage, intraventric

Interventions

Intervention1: 3 PERCENT HYPERTONIC SALINE AND MANNITOL COMBINE IN REDUCING RAISED INTRACRANIAL PRESSURE: CAN 3 PERCENT HYPERTONIC SALINE AND MANNITOL IS ABLE TO REDUCE INTRACRANIAL PRESSURE BETTER TH

Sponsors

AIIMS JODHPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients who are 18 years of age or older. 2. Acute stroke diagnosis (ischemic or haemorrhagic) confirmed by brain imaging with CT or MRI. 3. Clinical or radiological indications of high intracranial pressure (ICP): These include symptoms including cerebral Edema, papilledema, midline shift, diminished consciousness, obliteration of the basal cisterns, and ONSD greater than 5.0 mm. 4. Hemodynamically stable upon enrolment: Systolic blood pressure of 90 mmHg or above without inotropic assistance. 5. Based on clinical assessment, hyperosmolar treatment is anticipated to be necessary as part of routine ICP management. 6. Consent from the patient or their duly appointed representative 7. GCS score between 6-13

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To compare the reduction in ONSD in stroke patients receiving 3% hypertonic saline alone vs. those receiving 3% hypertonic saline with mannitol.Timepoint: baseline , 1 hour, 6 hour , 12 hour and 24 hour—

Secondary

MeasureTime frame
• To evaluate clinical improvement using tools like the NIH Stroke Scale & Glasgow Coma Scale. • To compare the incidence of adverse effects (renal dysfunction, electrolyte imbalance, rebound, ICP etc.) between the group. • To evaluate functional result (e.g., mRS) .Assessing hospital mortality; comparing hospital stay duration; & determining whether further surgical decompression is required Timepoint: Clinical improvement (NIHSS, GCS) at baseline, daily Day 1–3, & discharge; adverse effects (renal, electrolytes) daily & end of therapy; functional outcome (mRS) at discharge, optional 1-month follow-up; hospital mortality; hospital stay duration; need for surgical decompression recorded during hospitalization.—

Countries

India

Contacts

Public ContactDr Keshav Rajput

AIIMS JODHPUR

sdr.raghavendra@gmail.com8076472804

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026