Hepatic Encephalopathy
Conditions
Keywords
hepatic encephalopathy, hepatitis C, manganese, mortality, prognosis.
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.
Interventions
None listed
Sponsors
Hospital General Dr. Darío Fernández Fierro
National Institute of Neurology and Neurosurgery
Materno-Perinatal Hospital of the State of Mexico
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evolution | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manganese Levels | 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. |
Countries
Mexico
Participant flow
Recruitment details
Encephalopathic patients admitted at the Department of Internal Medicine of the General Hospital Dr. Darío Fernández Fierro after being stabilized at the Emergency Room
Pre-assignment details
They were consecutive patients males or females aged \> 18 years, with hepatic encephalopathy.
Participants by arm
| Arm | Count |
|---|---|
| Females Brain death | 4 |
| Males Brain death | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Females | Males | Total |
|---|---|---|---|
| Age, Continuous >=65 years | 67 years STANDARD_DEVIATION 0 | 72.5 years STANDARD_DEVIATION 3.53 | 70.66 years STANDARD_DEVIATION 4.04 |
| Age, Continuous Between 18 and 65 years | 52.33 years STANDARD_DEVIATION 3.05 | 56.66 years STANDARD_DEVIATION 6.65 | 54.5 years STANDARD_DEVIATION 5.2 |
| Age, Continuous | 56 years STANDARD_DEVIATION 7.74 | 63 years STANDARD_DEVIATION 10.02 | 59.88 years STANDARD_DEVIATION 9.29 |
| Baseline blood hemoglobin | 11.52 mg/dL STANDARD_DEVIATION 1.57 | 12.14 mg/dL STANDARD_DEVIATION 1.77 | 11.86 mg/dL STANDARD_DEVIATION 1.61 |
| Blood levels of manganese | 28.75 µg/L STANDARD_DEVIATION 9.47 | 18.5 µg/L STANDARD_DEVIATION 10.22 | 23.05 µg/L STANDARD_DEVIATION 10.72 |
| Region of Enrollment Mexico | 4 participants | 5 participants | 9 participants |
| Sex/Gender, Customized >= 65 years | 1 participants | 2 participants | 3 participants |
| Sex/Gender, Customized Between 18 and 65 years | 3 participants | 3 participants | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
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
Time frame: six months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Females | Clinical Evolution | Still alive | 3 participants |
| Females | Clinical Evolution | deaths | 1 participants |
| Males | Clinical Evolution | Still alive | 3 participants |
| Males | Clinical Evolution | deaths | 2 participants |
Comparison: Clinical evolution was reported as percentage (still alive or death after six months of follow up).p-value: 0.05Chi-squared
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.
Time frame: Up to six months we followed the recruited patients to determine who were still alive
Population: All patients attended at the Internal Medicine Service with Hepatic Encephalopathy were included. The analysis was per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Females | Manganese Levels | 28.75 μg/L | Standard Deviation 9.4 |
| Males | Manganese Levels | 18.5 μg/L | Standard Deviation 10.22 |
Comparison: Laboratory results were expressed in means and standard deviations. Between group comparisons (female versus male values) were made with the Mann-Whitney U test using the Statistical Package for Social Sciences (SPSS) program version 10 (SPSS Inc., North Carolina, USA).p-value: 0.05Wilcoxon (Mann-Whitney)