Manganese in Women With Encephalopathy

October 4, 2016 updated by: Materno-Perinatal Hospital of the State of Mexico

Manganese, Possible Factor of Higher Mortality in Women With Encephalopathy

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 03900
        • General Hospital "Dr. Darío Fernández Fierro"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Evolution
Time Frame: six months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manganese Levels
Time Frame: Up to six months we followed the recruited patients to determine who were still alive
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Materno-Perinatal Hospital of the State of Mexico

Collaborators

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"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (ESTIMATE)

September 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGDrDFF-Mn2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatic Encephalopathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe