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OpenTrials
Completed

NCT Number: NCT02460510

Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

3% Hypertonic saline

Drug

Primary outcomes

  1. To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure)

    Time frame: 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 outcomes

  1. Correlation of arterial NH3 to raised ICT (Intra cranial Tension).

    Time frame: 2 years

  2. Survival.

    Time frame: 28 days

  3. Length of ICU/hospital stay.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF: A Randomized Open -Label Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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