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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00670124
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : November 5, 2014
University Hospital Birmingham
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Dr. Fin Stolze Larsen, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Liver Failure Intracranial Hypertension Device: Hypothermia by the use of Blanketrol II, Cincinnati Sub-Zero Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial on the Effect of Mild Hypothermia on Intracranial Pressure in Patients With Hyperacute Liver Failure
Study Start Date : January 2005
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
No Intervention: 1
Standard medical treatment
Active Comparator: 2
Standard medical treatment plus hypothermia (33°C) maintained for 72 hours
Device: 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.
Other Name: Cooling device: Blanketrol II, Cincinnati Sub-Zero

Primary Outcome Measures :
  1. The effect of hypothermia on preventing development of ICP higher than 25 mmHg [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. The effect of hypothermia on preserving normal cerebral oxidative metabolism evaluated by cerebral microdialysis [ Time Frame: 72 hours ]
  2. The effect of hypothermia on severity of infections [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00670124

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United States, Illinois
Division of Hepatology, Feinberg School of Medicine, Northwestern University
Chicago, Illinois, United States, 60610
Department of hepatology, Rigshospitalet
Copenhagen, Denmark, 2100
United Kingdom
Dept. of Intensive Care
Birmingham, United Kingdom
Institute for Liver Studies, King`s College Hospital
London, United Kingdom
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital Birmingham
Feinberg School of Medicine, Northwestern University
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Principal Investigator: Fin S Larsen, MD Rigshospitalet, Denmark

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Responsible Party: Dr. Fin Stolze Larsen, Head of Research Unit, Rigshospitalet, Denmark Identifier: NCT00670124     History of Changes
Other Study ID Numbers: ALFHypothermia01
First Posted: May 1, 2008    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Intracranial Hypertension
Body Temperature Changes
Signs and Symptoms
Liver Diseases
Digestive System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dermatologic Agents