THERAPY DOSSIER · th-36c962b9c6b6

5% hypertonic saline; 20% mannitol

Drug · Unknown

No trauma translation Suggest a correction

Review required. This record is flagged as borderline.

This record is classified as “NO TRAUMA TRANSLATION”. Read the indication and notes below for the specific context.

Evidence & regulatory context

Mechanism: Unknown
Target: Not recorded
Injury models: TBI
Reported indication: Mannitol (osmotic diuretic) approved for reduction of elevated intracranial pressure and treatment of cerebral edema, and for osmotic diuresis; long-standing FDA approval
First approval: 1982
Development stage: Approved/standard-of-care osmotherapy for raised ICP & cerebral edema; modern comparative RCTs terminated/inconclusive
ChEMBL record: CHEMBL689 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Aridol kit; Bronchitol; Cordycepic acid; Crystalline mannitol extra-fine; Crystalline mannitol fine; Crystalline mannitol standard; Diosmol; D-(-)-mannitol; D-mannitol; E-421; E421; INS-421; INS NO.421; Isomalt impurity, mannitol-; Manna sugar
Note: supportive care (analgesia/osmotherapy), not injury-modifying; osmotherapy for ICP predates corpus (Wise & Chater 1961)

Clinical trials 9

3 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT01028339 ↗Injury indicationPHASE3terminated

Mannitol Versus Hypertonic Saline to Treat Intracranial Hypertension After Severe Traumatic Brain Injury

Traumatic Brain Injury

Enrolment: 30 · Results not recorded

NCT06914310 ↗Injury indicationPHASE2/PHASE3not yet recruiting

Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

Mild Traumatic Brain Injury · Moderate Traumatic Brain Injury (TBI)

Enrolment: 80 · Results not recorded

NCT00125229 ↗Injury indicationPhase not recordedterminated

Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Traumatic Brain Injury · Intracranial Hypertension

Enrolment: 10 · Results not recorded

NCT00447018 ↗PHASE4completed

Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure

Intracranial Hypertension

Enrolment: 20 · Results not recorded

NCT03573999 ↗PHASE4completed

Effect of Isosmotic Doses of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation in Supratentorial Craniotomies

Brain Edema · Metabolic Disturbance · Electrolyte and Fluid Balance Conditions

Enrolment: 54 · Results not recorded

NCT01887197 ↗PHASE1completed

Repeatability and Response Study of Absorptive Clearance Scans (hypertonic saline; mannitol)

Cystic Fibrosis

Enrolment: 24 · Results not recorded

NCT01108744 ↗NAwithdrawn

Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP)

Elevated Intracranial Pressure

Enrolment: 0 · Results not recorded

NCT00199511 ↗NAcompleted

Comparison of Equiosmolar Doses of Mannitol 20% Versus Hypertonic Saline 7.5% Infusion During Elective Craniotomies

Brain Tumor · Tumor, Brain · Brain Neoplasm · Neoplasm, Supratentorial · Tumor, Supratentorial

Enrolment: 162 · Results not recorded

NCT00916526 ↗NAcompleted

Exhaled NO and Bronchial Provocation With Mannitol in Chronic Cough

Cough · Bronchial Hyperreactivity

Enrolment: 30 · Results not recorded

Preclinical evidence 4

2 studies reported at therapy level; 4 evidence entries itemised.

PMID 22846939 ↗2012Mixed findings

Similar effects of hypertonic saline and mannitol on the inflammation of the blood-brain barrier microcirculation after brain injury in a mouse model.

MouseTBIUnspecifiedCD1MaleIntravenousSingle equiosmolar dose of 20% mannitol or 5% hypertonic sa…After injury

Model: Simulated traumatic brain injury by craniotomy with local suffusion of the brain surface with interleukin 1 beta (100 ng/0.1 mL), with intravital microscopy of pial venules

Neither osmotherapy produced significant differences in neutrophil rolling or adhesion or in vessel permeability, although both trended higher with hypertonic saline; brain and lung oedema were greater with mannitol than with hypertonic saline compared with controls (p = 0.05). The two agents had i…

Extraction: extract · Supplied extraction confidence: 0.65. Machine-extracted fields require source verification.

PMID 30106807 ↗2018Reported benefit

Effect of Mannitol Infusion on Optic Nerve Injury After Acute Traumatic Subarachnoid Hemorrhage and Brain Injury.

RatTBIWeight-drop / impact-accelerationWistarMalen = 30 rats in total, 10 per groupIntravenous1 mg/kg

Model: Weight-drop impact acceleration traumatic brain injury with traumatic subarachnoid haemorrhage, assessing optic nerve injury

Optic nerve glutathione peroxidase was significantly higher and interleukin 1 beta significantly lower in the mannitol group than in the untreated injury group, suggesting protection of the optic nerve from secondary injury.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.72. Machine-extracted fields require source verification.

PMID 20823568 ↗2010

Effects of combination treatment with dexamethasone and mannitol on neuronal damage and survival in experimental heat stroke

RatTBI

Extraction: mesh. Machine-extracted fields require source verification.

PMID 11770037 ↗2001

Effects of mannitol on the acute lung injury induced by oleic acid in rats

RatTBI

Extraction: mesh. Machine-extracted fields require source verification.

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