Acute Liver Failure
Conditions
Brief summary
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.
Interventions
DRUGMannitol
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Acute Liver Failure with age \>18 yrs * Grade III or grade IV HE with raised ICP * Patient's next-of-kin consenting for the study protocol.
Exclusion criteria
* Patients with ocular trauma. * K/c/o DCM, congestive heart failure, cerebral aneurysm, intracranial pathology * Serum Na\>160 and s creat\>1.5 mg% with oligurea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure) | 12 hours | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of arterial NH3 to raised ICT (Intra cranial Tension). | 2 years |
| Survival. | 28 days |
| Length of ICU/hospital stay. | 2 years |
Countries
India
Outcome results
None listed