Plain English Summary
Background and study aims
Tick-born encephalitis virus (TBEV) is an infectious viral disease that is spread to humans by a bite from a small bug called a tick. TBEV is rare but occurs in some European and Asian countries. It can become very serious if the virus spreads to the brain (causing encephalitis (swelling of the brain)) or to the tissue that covers the brain and spinal cord (causing meningitis). The symptoms of TBEV can be classified by phases. The first phase of symptoms occur one month after a tick bite and can include headaches, vertigo (a feeling that everything around you is moving or spinning), joint and muscle pain. After these symptoms, most people can make a complete recovery. However, some patients may experience a second phase of symptoms which include fever, headaches, neck stiffness, seizures, sensitivity to light, paralysis (unable to move body parts), confusion, drowsiness or disorientation. These symptoms are very serious and usually require hospitalization. In order to help lower the levels of pressure on the brain, Mannitol is usually given to patients. Mannitol is a diuretic which promotes urination (peeing) in order to get rid of extra fluids and salt in the body. However, Mannitol can lead to dangerously low water levels in the body as it lowers the levels of electrolytes (salts) in the body. Therefore, treating TBEV with Mannitol requires monitoring of the patient’s water and electrolyte levels. The aim of this study is assess the influence of one dose of 15% Mannitol on patient’s hydration (water levels).
Who can participate?
Adults aged 18 and older who are diagnosed with meningitis/encephalitis.
What does the study involve?
Participants receive the standard 0.25g/kg 15% dose of Mannitol (given through a needle in the arm) as treatment for meningitis/encephalitis. Participants have blood samples taken prior to the dose of Mannitol and one hour after receiving the Mannitol dose. The blood samples are measured for electrolyte levels. Participants also are measured for their hydration before the Mannitol dose and one after the dose using a whole body scan. This measures the water levels in the body. Participants undergo the standard hospitalisation period and are followed up with out-patient visits for six months.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
Medical University in Białystok (Poland)
When is the study starting and how long is it expected to run for?
July 2016 to December 2019
Who is funding the study?
Medical University Białystok (Poland)
Who is the main contact?
Dr Piotr Czupryna
Trial website
Contact information
Type
Scientific
Primary contact
Dr Piotr Czupryna
ORCID ID
http://orcid.org/0000-0002-0072-2180
Contact details
Medical University in Białystok
Department of Infectious Diseases and Neuroinfections
Zurawia 14
Bialystok
15540
Poland
Type
Scientific
Additional contact
Dr Anna Moniuszko-Malinowska
ORCID ID
Contact details
Medical University in Białystok
Department of Infectious Diseases and Neuroinfections
Zurawia 14
Bialystok
15540
Poland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1/2017
Study information
Scientific title
Assessment of one dose Mannitol influence on hydration and electrolytes concentration in patients with viral meningitis
Acronym
MICHA
Study hypothesis
Mannitol significantly influences on patients hydration and electrolyte balance.
Ethics approval
Ethical Committee by Medical University of Bialystok, 28/05/2015, ref: R-I-002/214/2015
Study design
Observational single-centre case series study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Tick-borne encephalitis/meningitis
Intervention
All patients with meningitis/encephalitis receive Mannitol as a standard treatment. However, participants in this trial are monitored more closely for potential water and electrolytes balance in order to properly adjust the supplmentation.
Participants are treated with a 0.25 g/kg 15% Mannitol dose given intravenously. In all participants, electrolyte (Na, K, Cl) and creatinine concentrations are measured using blood tests. The first blood sample is taken before the first dose of Mannitol. A second blood sample is taken one hour after the Mannitol administration.
Participants hydration status is measured before and one hour after Mannitol implementation by whole body bioelectrical impedance with multiple frequency equipment (BodyStat QuadScan 4000). The parameters that are analysed are: Total Body Water volume (TBW) in liters and percent of body mass, Internal Body Water volume (IBW) in liters and percent of body mass, External Body Water volume (EBW) in liters and percent of body mass, third space body water.
Participants undergo the standard observation period of patients with meningitis/encephalitis (two weeks of hospitalization) and are followed-up according to the standard level of care for six months with periodic visits to the Out-Patients Department.
Intervention type
Drug
Phase
Not Applicable
Drug names
Mannitol
Primary outcome measure
1. Hydration status is measured using whole body bioelectrical impedance with multiple frequency equipment BodyStat QuadScan 4000 at baseline and one hour
2. Electrolyte concentration in blood is analyzed in the hospital laboratory in accordance with standardized methodology at baseline and one hour
Secondary outcome measures
1. Total Body Water volume (TBW) is measured using whole body bioelectrical impedance with multiple frequency equipment BodyStat QuadScan 4000 at baseline and one hour
2. Internal body water volume is measured using whole body bioelectrical impedance with multiple frequency equipment BodyStat QuadScan 4000 at baseline and one hour
3. External Body water volume is measured using whole body bioelectrical impedance with multiple frequency equipment BodyStat QuadScan 4000 at baseline and one hour
4. Third space body water and electrolytes concentration is measures using whole body bioelectrical impedance with multiple frequency equipment BodyStat QuadScan 4000 at baseline and one hour
Overall trial start date
01/08/2016
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults aged 18 years old and older
2. Hospitalised due to tick-borne encephalitis in the Department of Infectious Diseases and Neuroinfections Medical University in Bialystok
3. Tick-borne encephalitis diagnosed based on clinical picture, cerebrospinal fluid (CSF) examination and specific antibodies presence in serum and TBE antibodies titer measured with Enzygnost Anti-TBE/FSME Virus (IgG, IgM) Siemens test
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Lack of agreement to study terms
Recruitment start date
01/08/2016
Recruitment end date
01/08/2019
Locations
Countries of recruitment
Poland
Trial participating centre
Medical University in Białystok
Department of Infectious Diseases and Neuroinfections
Zurawia 14
Bialystok
15540
Poland
Sponsor information
Organisation
Medical University Białystok
Sponsor details
Jana Kilinskiego 1
Bialystok
15089
Poland
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Medical University Białystok
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Preliminary results are planned to be published and final results are planned to be published in a high-impact peer reviewed journal.
IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Piotr Czupryna; email: avalon-5@wp.pl
Intention to publish date
31/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN48274252_PIS_20Mar17_Polish.doc Uploaded 04/04/2017