Condition category
Infections and Infestations
Date applied
11/03/2017
Date assigned
04/04/2017
Last edited
04/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

www.umb.edu.pl

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

Editorial Notes