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Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations. Patients would also be screened for the assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of 144-155 mmol/L .Both the groups would receive other supportive measures such as head end elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard medical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mannitol | Experimental | Treatment with mannitol intravenous (IV) bolus over 20 to 30 minutes. The dose is 0.25 g/kg IV as a 20% solution repeated every 4th hourly.(8) Mannitol infusion to be stopped if s osmolarity >320mm |
|
| 3% hypertonic saline | Active Comparator | Treatment with 3% hypertonic saline as continuous infusion. Continuous 3% NaCl infusion to be started at a rate of 25ml /hr and titrated q4hrs per sliding scale to achieve a target serum sodium level of <160 mmol/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mannitol | Drug |
| ||
| 3% hypertonic saline |
| Measure | Description | Time Frame |
|---|---|---|
| To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure) | ICP (Intra Cranial Pressure) as assessed by ONSD (Optic Nerve Sheet Diameter) < 5mm PS<1.2 Pupils - RTL(reaction to light) {if initially NTR(no reaction to light)} BP<150/90(if initially high) Pulse >60( if < 60) | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of arterial NH3 to raised ICT (Intra cranial Tension). | 2 years | |
| Survival. | 28 days | |
| Length of ICU/hospital stay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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|
| 2 years |
| D006982 |
| Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |