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Comparison of 10 percent Mannitol and 10 percent Glycerol Combination drug with 3 percent Hypertonic Saline on Cerebral Blood Flow and clinical outcome in adult Patients with Moderate to Severe Traumatic Brain Injury in

Comparison of 10 percent Mannitol and 10 percent Glycerol Combination with 3 percent Hypertonic Saline on Change in Mean Cerebral Blood Flow Velocity in Patients with Moderate to Severe Traumatic Brain Injury: A Randomized Clinical Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091874
Enrollment
148
Registered
2025-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: ADMINISTRATION OF 10 PERCENT GLYCEROL AND 10 PERCENT MANNITOL COMBINATION IN MODERATE TO SEVERE TRAUMATIC BRAIN INJURY: AFTER ADMISSION TO THE NTICU, PATIENTS WILL RECEIVE A COMBINATION

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Moderate to severe traumatic brain injury patients Aged 18 to 65 GCS less than or equal to 12

Exclusion criteria

Exclusion criteria: Failure to give consent Polytrauma patients Cerebrospinal fluid leakage or drainage With anuria or Oliguria Renal failure, liver failure and decompensated cardiac failure Hemoglobin less than 8 Serum osmolality greater than 320 mOsm per L Serum sodium lessthan 130 or greater than 150 mEq per L Pregnant Patients with uncontrolled systemic illness

Design outcomes

Primary

MeasureTime frame
Primary outcome To compare the change in mean cerebral blood flow velocity (MCBFV) of the middle cerebral artery at 30 minutes after administration of the drugTimepoint: Primary outcome To compare the change in mean cerebral blood flow velocity (MCBFV) of the middle cerebral artery at 30 minutes after administration of the drug—

Secondary

MeasureTime frame
Secondary outcome Mean cerebral blood flow velocity Systolic peak blood flow velocity End-diastolic blood flow velocity pulsatility index AND resistance index using TCCD Optic nerve sheath diameter ONSD of both the eyes Serum electrolytes osmolality Fluid status Input Output Heart rate & Mean arterial pressure Total ICU & Hospital stay Modified Rankin scale score at discharge Timepoint: MCBFV Systolic peak blood flow velocity End-diastolic blood flow velocity pulsatility index resistance index ONSD Vitals at T0 starting the infusion T1 termination of the infusion T2 15 min after the termination of the infusion T3 at 30 min after the termination of the infusion T4 at 60 min after the termination of the infusion Serum electrolytes osmolality at T0T4 24 hour input output till 48 hours Baseline 48 hour CT findings Total ICU Hospital MRS score at discharge & at 3 months—

Countries

India

Contacts

Public ContactAMIYA KUMAR BARIK

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH

AMIYABARIK.SCB@GMAIL.COM8052919523

Outcome results

None listed

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