NCT00670124

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

6 years

First QC Date

April 29, 2008

Last Update Submit

November 4, 2014

Conditions

Acute Liver FailureIntracranial Hypertension

Outcome Measures

Primary Outcomes (1)

  • The effect of hypothermia on preventing development of ICP higher than 25 mmHg

    72 hours

Secondary Outcomes (2)

  • The effect of hypothermia on preserving normal cerebral oxidative metabolism evaluated by cerebral microdialysis

    72 hours

  • The effect of hypothermia on severity of infections

    1 week

Study Arms (2)

1

NO INTERVENTION

Standard medical treatment

2

ACTIVE COMPARATOR

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

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

Interventions

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

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

Also known as: Cooling device: Blanketrol II, Cincinnati Sub-Zero
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • no or withdrawn informed consent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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Division of Hepatology, Feinberg School of Medicine, Northwestern University

Chicago, Illinois, 60610, United States

Location

Department of hepatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Dept. of Intensive Care

Birmingham, United Kingdom

Location

Institute for Liver Studies, King's College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Liver Failure, AcuteIntracranial Hypertension

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Fin S Larsen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Unit

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

January 1, 2005

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

GB(2)US(1)DK(1)