Hepatic EncephalopathyNCT00985010

Manganese in Women With Encephalopathy

An observational study of Hepatic Encephalopathy, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatic Encephalopathy
How many people: 9 participants
Where: 1 siteMexico
Study dates: Jan 2003to Jan 2005
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Portal bypass surgery
Cancer of any localization
Known malignancy and other severe diseases which shorten life expectancy < 6 months
Psychiatric illness

Trial locations and contacts

1 site in 1 country.

Mexico1 site

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

Other trials in Mexico

About this study

Official title: 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.

Conditions: Hepatic Encephalopathy
Keywords: hepatic encephalopathy, hepatitis C, manganese, mortality, prognosis.
Medical subject headings: Hepatic Encephalopathy, Hepatitis C

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: six months

Secondary outcomes (1)

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.
Measured: Up to six months we followed the recruited patients to determine who were still alive

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Jan 2005

First posted25 Sep 2009 (estimated)
Study startJan 2003
Primary completionJan 2005
Study completionJan 2005

Why it stopped: The authors finished their jobs in the hospitals where the study was begun.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985010
Sponsor's protocol ID: HGDrDFF-Mn2008
Status last verified: Aug 2009
First submitted: 5 Jan 2009
Last updated: 8 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zeron HM, Rodriguez MR, Montes S, Castaneda CR. Blood manganese levels in patients with hepatic encephalopathy. J Trace Elem Med Biol. 2011 Dec;25(4):225-9. doi: 10.1016/j.jtemb.2011.07.003. Epub 2011 Oct 4.
PubMed 21975221

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatic Encephalopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Manganese, Possible Factor of Higher Mortality in Women With Encephalopathy
ClinicalTrials.gov ID: NCT00985010
Acronym / sponsor ID: HGDrDFF-Mn2008
Conditions: Hepatic Encephalopathy
Keywords: hepatic encephalopathy, hepatitis C, manganese, mortality, prognosis.
Study type: Observational
Recruitment status: TerminatedReason stopped: The authors finished their jobs in the hospitals where the study was begun.
Enrolment: 9 participants (actual)
Lead sponsor: Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
Collaborators: Hospital General "Dr. Darío Fernández Fierro", National Institute of Neurology and Neurosurgery, Mexico
Study start: Jan 2003
Primary completion: Jan 2005 (actual)
Study completion: Jan 2005 (actual)
First posted: 25 Sep 2009 (estimated)
Results: Posted 25 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Hypothesis:

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

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed by their families.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

Portal bypass surgery
Cancer of any localization
Known malignancy and other severe diseases which shorten life expectancy < 6 months
Psychiatric illness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

Manganese Levels
Time frame: Up to six months we followed the recruited patients to determine who were still alive

Results and safety

Results posted to the registry on 25 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Females	4	4
Males	5	5

Primary outcome: Clinical Evolution

Time frame: six months. Number. Unit: participants

Measure	Females n = 4	Males n = 5
Still alive	3	3
deaths	1	2

Females vs Males: Mean Difference (Final Values): 15, p = 0.05, Chi-squared

Population analysed: We made a clinical follow up from nine encephalopathic patients. After six months we studied the differences in Mn, hemoglobin, etc., between those patients still alive and those who died.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Females	0 of 4 (0%)	0 of 4 (0%)	Not reported
Males	0 of 5 (0%)	0 of 5 (0%)	Not reported

Limitations and caveats (from the sponsor): Small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21975221Zeron HM, Rodriguez MR, Montes S, Castaneda CR. Blood manganese levels in patients with hepatic encephalopathy. J Trace Elem Med Biol. 2011 Dec;25(4):225-9. doi: 10.1016/j.jtemb.2011.07.003. Epub 2011 Oct 4.

Related trials for Hepatic Encephalopathy

Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingPhase 4
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Liver Cirrhosis, Sleep Disturbance
Not yet recruiting
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hugo Mendieta Zerón, PhD principal investigator

Materno-Perinatal Hospital of the State of Mexico

Camilo Rios Castañeda, PhD study director

National Institute of Neurology and Neurosurgery, Mexico

Mónica Rodríguez Rodríguez, MD study chair

General Hospital "Dr. Darío Fernández Fierro"

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatic Encephalopathy, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Evolution (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985010, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.