Hypothermia to Prevent High Intracranial Pressure in Patients With Acute Liver Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-06-30

Brief Summary

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Treatment options in patients with high intracranial pressure due to acute liver failure are limited. This study intends to evaluate the effect of prophylactic hypothermia on preventing high intracranial pressure and compromised cerebral oxidative metabolism.

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Detailed Description

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Acute liver failure (ALF) is associated with a high mortality. With severe hepatic encephalopathy and elevated arterial ammonia concentration (\< 200 micromol/L) more than 50% of the patients will develop high intracranial pressure (ICP) and risk cerebral incarceration and death. The therapeutic options are limited in treating and preventing this condition and new interventions are much sought after. As in hypothermia used for patients after cardiac resuscitation it could be speculated that hypothermia and the reduced cerebral metabolic rate would contribute to neuroprotection and reduce the risk of cerebral hypertension in patients with ALF. We have designed this open, randomized and unblinded study in order to evaluate the effect of prophylactic hypothermia on ICP, cerebral hemodynamics and oxidative metabolism. Patients are randomized to standard medical treatment (SMT) or SMT and hypothermia 33° C for 72 hours using a cooling mattress (Blanketrol II, Cincinnati Sub-Zero). All patients will receive mechanical ventilation, antibiotics, inotropic support and monitored with invasive and non-invasive equipment in accordance to local guidelines. In Copenhagen monitoring cerebral hemodynamics includes:

Placement of a intracranial pressure measuring catheter (Camino (R), Integra) for monitoring ICP. Furthermore, a microdialysis catheter (CMA-70) placed in brain cortex is used for monitoring brain metabolism. Finally, cerebral perfusion can be monitored by measuring mean flow velocity using transcranial doppler and/or oxygen saturation in blood from the jugular vein.

Ethical considerations:

The Helsinki II declaration will be followed and informed consent is mandatory for enrollment. In any patient where hypothermia is believed or suspected to be harmful the study should be stopped and the primary investigator should be notified immediately. All adverse effects will be recorded and published together with the full paper.

Conditions

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Acute Liver Failure Intracranial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard medical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Standard medical treatment plus hypothermia (33°C) maintained for 72 hours

Group Type ACTIVE_COMPARATOR

Hypothermia by the use of Blanketrol II, Cincinnati Sub-Zero

Intervention Type DEVICE

The patients are placed on a cooling mattress and body-core temperature is regulated to 33° C.

Interventions

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Hypothermia by the use of Blanketrol II, Cincinnati Sub-Zero

The patients are placed on a cooling mattress and body-core temperature is regulated to 33° C.

Intervention Type DEVICE

Other Intervention Names

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Cooling device: Blanketrol II, Cincinnati Sub-Zero

Eligibility Criteria

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Inclusion Criteria

* acute liver failure
* and hepatic encephalopathy stage 3 or 4
* and informed and written consent by closest relative(s)
* and arterial ammonia concentration above 150 micromol/L or clinical suspicion of cerebral edema
* and an ICP-measuring device

Exclusion Criteria

* no or withdrawn informed consent
* pregnant or breast feeding women
* uncontrollable infection
* hemodynamically instable patients
* active bleeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No