NCT00985010

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
terminated

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, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

September 25, 2009

Completed
Last Updated

November 8, 2016

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

January 5, 2009

Results QC Date

January 5, 2009

Last Update Submit

October 4, 2016

Conditions

Hepatic Encephalopathy

Keywords

hepatic encephalopathyhepatitis Cmanganesemortalityprognosis.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Manganese Levels

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital "Dr. Darío Fernández Fierro"

México, D.f., 03900, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 21975221DERIVED

MeSH Terms

Conditions

Hepatic EncephalopathyHepatitis C

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis

Limitations and Caveats

Small numbers of subjects analyzed

Results Point of Contact

Title
Hugo Mendieta Zerón
Organization
Materno-Perinatal Hospital of the State of Mexico
mezh_74@yahoo.com
+52-722-2176605

Study Officials

  • Hugo Mendieta Zerón, PhD

    Materno-Perinatal Hospital of the State of Mexico

    PRINCIPAL INVESTIGATOR

  • Camilo Rios Castañeda, PhD

    National Institute of Neurology and Neurosurgery

    STUDY DIRECTOR

  • Mónica Rodríguez Rodríguez, MD

    General Hospital "Dr. Darío Fernández Fierro"

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2009

First Posted

September 25, 2009

Study Start

January 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

November 8, 2016

Results First Posted

September 25, 2009

Record last verified: 2009-08

Locations

ME(1)