Trial Outcomes & Findings for Manganese in Women With Encephalopathy (NCT NCT00985010)

Last Updated: 2016-11-08

Results Overview

Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room

Recruitment status

TERMINATED

Target enrollment

9 participants

Primary outcome timeframe

six months

Results posted on

2016-11-08

Participant Flow

Encephalopathic patients admitted at the Department of Internal Medicine of the General Hospital "Dr. Darío Fernández Fierro" after being stabilized at the Emergency Room

They were consecutive patients males or females aged \> 18 years, with hepatic encephalopathy.

Participant milestones

Participant milestones
Measure	Females Brain death	Males Brain death
Overall Study STARTED	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Manganese in Women With Encephalopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Females n=4 Participants Brain death	Males n=5 Participants Brain death	Total n=9 Participants Total of all reporting groups
Age, Continuous Between 18 and 65 years	52.33 years STANDARD_DEVIATION 3.05 • n=5 Participants	56.66 years STANDARD_DEVIATION 6.65 • n=7 Participants	54.5 years STANDARD_DEVIATION 5.2 • n=5 Participants
Age, Continuous >=65 years	67 years STANDARD_DEVIATION 0 • n=5 Participants	72.5 years STANDARD_DEVIATION 3.53 • n=7 Participants	70.66 years STANDARD_DEVIATION 4.04 • n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 7.74 • n=5 Participants	63 years STANDARD_DEVIATION 10.02 • n=7 Participants	59.88 years STANDARD_DEVIATION 9.29 • n=5 Participants
Sex/Gender, Customized Between 18 and 65 years	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Sex/Gender, Customized >= 65 years	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Mexico	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Baseline blood hemoglobin	11.52 mg/dL STANDARD_DEVIATION 1.57 • n=5 Participants	12.14 mg/dL STANDARD_DEVIATION 1.77 • n=7 Participants	11.86 mg/dL STANDARD_DEVIATION 1.61 • n=5 Participants
Blood levels of manganese	28.75 µg/L STANDARD_DEVIATION 9.47 • n=5 Participants	18.5 µg/L STANDARD_DEVIATION 10.22 • n=7 Participants	23.05 µg/L STANDARD_DEVIATION 10.72 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room

Outcome measures

Outcome measures
Measure	Females n=4 Participants Brain death	Males n=5 Participants Brain death
Clinical Evolution Still alive	3 participants	3 participants
Clinical Evolution deaths	1 participants	2 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Females n=4 Participants Brain death	Males n=5 Participants Brain death
Manganese Levels	28.75 μg/L Standard Deviation 9.4	18.5 μg/L Standard Deviation 10.22

Adverse Events

Females

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Males

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hugo Mendieta Zerón

Materno-Perinatal Hospital of the State of Mexico

Phone: +52-722-2176605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place