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Manganese in Women With Encephalopathy

This study has been terminated.
(The authors finished their jobs in the hospitals where the study was begun.)
Sponsor:
Collaborators:
Hospital General "Dr. Darío Fernández Fierro"
National Institute of Neurology and Neurosurgery
Information provided by:
Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier:
NCT00985010
First received: January 5, 2009
Last updated: July 26, 2010
Last verified: August 2009
History of Changes
  Purpose

Objective:

Report manganese serum levels and mortality in encephalopathic patients.

Patients and participants:

Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed by their families.

Interventions:

Patients' clinical characteristics as well as biochemical tests of renal function, hemoglobin, glucose and albumin levels were obtained as well as a blood sample to analyze manganese levels with a graphite furnace atomic absorption spectrometer.

Hypothesis:

There is a difference in the manganese levels between male and female patients.


Condition
Hepatic Encephalopathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Manganese, Possible Factor of Higher Mortality in Women With Encephalopathy

Resource links provided by NLM:

Drug Information available for: Manganese
U.S. FDA Resources

Further study details as provided by Materno-Perinatal Hospital of the State of Mexico:

Primary Outcome Measures:
  • Clinical Evolution [ Time Frame: six months ] [ Designated as safety issue: No ]
    Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room


Secondary Outcome Measures:
  • Manganese Levels [ Time Frame: Up to six months we followed the recruited patients to determine who were still alive ] [ Designated as safety issue: No ]
    From encephalopathic patients, we took individual blood samples, analyzed in the biochemistry laboratory at the National Institute of Neurology and Neurosurgery, Mexico, City, with a graphite furnace atomic absorption spectrometer, according to the technique reported by Pleban.


Enrollment: 9
Study Start Date: January 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed by their families.

Criteria

Inclusion Criteria:

  • Consecutive patients aged > 18 years
  • With hepatic encephalopathy
  • Informed consent signed by their families

Exclusion Criteria:

  • Portal bypass surgery
  • Cancer of any localization
  • Known malignancy and other severe diseases which shorten life expectancy < 6 months
  • Psychiatric illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985010

Locations
Mexico
General Hospital "Dr. Darío Fernández Fierro"
Mexico, D.f., Mexico, 03900
Sponsors and Collaborators
Materno-Perinatal Hospital of the State of Mexico
Hospital General "Dr. Darío Fernández Fierro"
National Institute of Neurology and Neurosurgery
Investigators
Principal Investigator: Hugo Mendieta Zerón, PhD Materno-Perinatal Hospital of the State of Mexico
Study Director: Camilo Rios Castañeda, PhD National Institute of Neurology and Neurosurgery
Study Chair: Mónica Rodríguez Rodríguez, MD General Hospital "Dr. Darío Fernández Fierro"
  More Information

No publications provided by Materno-Perinatal Hospital of the State of Mexico

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hugo Mendieta Zerón, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier: NCT00985010     History of Changes
Other Study ID Numbers: HGDrDFF-Mn2008
Study First Received: January 5, 2009
Results First Received: January 5, 2009
Last Updated: July 26, 2010
Health Authority: Mexico: Ethics Committee

Keywords provided by Materno-Perinatal Hospital of the State of Mexico:
hepatic encephalopathy
hepatitis C
manganese
mortality
prognosis.

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion
 Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Manganese
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013