Protocol summary

Study aim
Evaluation of the effect of prehydration on the fatigue and exhaustion of patients undergoing plasma therapY
Design
This cross-over interventional intervention is done. Patients undergoing Plasmapheresis are randomly assigned to one of two groups (first, a common fluid therapy, then a pre-term fluid therapy), or (b) an early treatment fluid, followed by a regular liquid therapy. At the start of the plasma milling and during it (by the researcher) and then (at home by a checklist that was previously trained to the patient by the method of completing it, until the next meeting is completed and will be delivered at the next meeting), the fatigue with The tool (RFS) and thirst are measured with the VAS visual simulation tool. In the usual fluid therapy, the plasma is first removed and the fluid is treated according to the protocol. In premature fluid therapy, 300 cc of the prescribed serum is first infused and the plasma is removed immediately, and the rest of the fluid is infused in accordance with the protocol during plasma therapy. This two-session procedure (each session is 2-4 hours) is repeated, and in the next two sessions, the fluid administration procedure is changed.
Settings and conduct
This cross-over interventional intervention is done. Patients undergoing Plasmapheresis are randomly assigned to one of two groups (first, a common fluid therapy, then a pre-term fluid therapy), or (b) an early treatment fluid, followed by a regular liquid therapy. At the start of the plasma milling and during it (by the researcher) and then (at home by a checklist that was previously trained to the patient by the method of completing it, until the next meeting is completed and will be delivered at the next meeting), the fatigue with The tool (RFS) and thirst are measured with the VAS visual simulation tool. In the usual fluid therapy, the plasma is first removed and the fluid is treated according to the protocol. In premature fluid therapy, 300 cc of the prescribed serum is first infused and the plasma is removed immediately, and the rest of the fluid is infused in accordance with the protocol during plasma therapy. This two-session procedure (each session is 2-4 hours) is repeated, and in the next two sessions, the fluid administration procedure is changed.
Participants/Inclusion and exclusion criteria
Inclusion criteria  The desire to participate in the study Age between 18-60 years Iranian nationality Alert Awareness of the person and time and place Use of the drug for a period of 4 hours before plasma therapy Have written consent to participate in the research. Ability to speak Persian   Literacy reading and writing According to the prescribing physician, you need to carry out plasma therapy Drug addiction Exit criteria Get sedative medications such as midazolam  Exercising physical activity or tolerating mental stress that causes fatigue Infections that cause weakness or fever like colds, allergies and ... Unwillingness to continue cooperation in the study Fewer than four sessions require plasma transcription Getting housing or sedation during the Plasmapheresis session
Intervention groups
Group A Group b
Main outcome variables
Decrease fatigue Reduce thirst

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170812035650N2
Registration date: 2018-01-27, 1396/11/07
Registration timing: registered_while_recruiting

Last update: 2018-01-27, 1396/11/07
Update count: 0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
manizheh hoseinzadeh
Name of organization / entity
Mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 3871 1584
Email address
hoseinzadehgm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2018-01-03, 1396/10/13
Expected recruitment end date
2018-07-04, 1397/04/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of early rehydration on fatigue and thirst in patients undergoing plasmapheresis
Public title
evaluation of the effect of pre-hydration on the fatigue and exhaustion of patients undergoing plasma therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Be to Iran dont be addicted to not use housing
Exclusion criteria:
----
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
does not have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of mashhad university of medical sciences
Street address
rezashahr
City
mashhad
Province
Razavi Khorasan
Postal code
9176936939
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
1396.254

Health conditions studied

1

Description of health condition studied
patient undergoing plasmapheresis
ICD-10 code
M35.9
ICD-10 code description
Autoimmune disease (systemic) NOS

Primary outcomes

1

Description
fatigue
Timepoint
during and after plasmapheresis
Method of measurement
with scale

2

Description
thirst
Timepoint
during and after plasmapheresis
Method of measurement
with scale

Secondary outcomes

1

Description
blood presure
Timepoint
during plasmapheresis
Method of measurement
Barometer

Intervention groups

1

Description
early rehydration
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
seyed reza mazloum
Street address
Daneshgah
City
mashhad
Province
Razavi Khorasan
Postal code
911111111
Phone
+98 51 3852 8514
Email
hoseinzadehgm1@mums.ac.ir

2

Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
seyed reza mazloum
Street address
Daneshgah
City
mashhad
Province
Razavi Khorasan
Postal code
911111111
Phone
+98 51 3852 8513
Email
hoseinzadehgm1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
seyed reza mazloum
Street address
Daneshgah
City
mashhad
Province
Razavi Khorasan
Postal code
911111111
Phone
+98 51 3852 8513
Email
hoseinzadehgm1@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
mashhad university of medical science
Full name of responsible person
seyed reza mazloum
Position
Nursing Education master
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
nursing school
City
mashhad
Province
Razavi Khorasan
Postal code
91111111
Phone
+51 38591511
Fax
Email
MazlomSR@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
mashhad university of medical science
Full name of responsible person
seyed reza mazloum
Position
Nursing Education master
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
nursing school
City
mashhad
Province
Razavi Khorasan
Postal code
91111111
Phone
+51 38591511
Fax
Email
MazlomSR@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
mashhad university of medical science
Full name of responsible person
seyed reza mazloum
Position
Nursing Education master
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
nursing school
City
mashhad
Province
Razavi Khorasan
Postal code
91111111
Phone
+51 38591511
Fax
Email
MazlomSR@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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