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NCT00985010 Clinical Trial

Manganese in Women With Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:
Manganese, Possible Factor of Higher Mortality in Women With Encephalopathy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00985010
Other study ID # HGDrDFF-Mn2008
Secondary ID
Status Terminated
Phase N/A
First received January 5, 2009
Last updated July 26, 2010
Start date January 2003
Est. completion date January 2005

Study information
Verified date August 2009
Source Materno-Perinatal Hospital of the State of Mexico
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 9
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Mexico General Hospital "Dr. Darío Fernández Fierro" Mexico D.f.

Sponsors (3)
Lead Sponsor Collaborator
Materno-Perinatal Hospital of the State of Mexico Hospital General "Dr. Darío Fernández Fierro", National Institute of Neurology and Neurosurgery

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Evolution Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room six months No
Secondary Manganese Levels 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. Up to six months we followed the recruited patients to determine who were still alive No
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