Protocol summary

Summary
Two methods of Sponge cooling with Ice packs on controlling of fever of the febrile patients in intensive care unit will be compared. Inclusion Criteria: not having renal failure and electrolyte disturbance; not taking blood during past 24 hours. Exclusion Criteria: shivering; Resistance fever above 40 degree of centigrade. 60 febrile patients hospitalized in critical care unit will allocated into two groups. In group 1, all patients will receive Sponge cooling with water 1 to 3 degree of centigrade on their axillary and groin areas up to 3 hours. In group 2, all patients will receive Ice packs on their axillary and groin areas up to 3 hours. Then the rate of fever of all patients will measure every 15 minutes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101730294N2
Registration date: 2016-10-23, 1395/08/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Mansoreh Karimikia
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 4702
Email address
m.karimikia@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Arak University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of sponge cooling and ice packs on controlling of fever in febrile patients in intensive care units
Public title
Effect of sponge cooling and ice packs on controlling of fever
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Not having renal failure and electrolyte disturbance; not taking blood during past 24 hours. Exclusion Criteria: shivering; Resistance fever above 40 degree of centigrade.
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Arak University of Medical Sciences
Street address
Sardasht Sq.
City
Arak
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
]IR. ARAKMU.REC.1395.211

Health conditions studied

1

Description of health condition studied
Fever
ICD-10 code
R50.9
ICD-10 code description
Fever, unspecified

Primary outcomes

1

Description
Fever
Timepoint
Every 15 minutes
Method of measurement
Tempanic Termometer

Secondary outcomes

empty

Intervention groups

1

Description
In group 1, all patients will receive Sponge cooling with water 1 to 3 degree of centigrade on their axillary and groin areas up to 3 hours.
Category
Treatment - Other

2

Description
In group 2, all patients will receive Ice packs on their axillary and groin areas up to 3 hours.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valie Asr Hospital
Full name of responsible person
Mansoreh Karimikia
Street address
Sarsasht Sq.
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor Of Research, Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiei
Street address
Sardasht Sq.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor Of Research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mansoreh Karimikia
Position
Master of Sciences Student
Other areas of specialty/work
Street address
Sadasht Sq.
City
Arak
Postal code
Phone
+98 86 3417 3545
Fax
Email
m.karimikia@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mansoreh Karimikia
Position
Student of Master of Science
Other areas of specialty/work
Street address
Sardash Sq.
City
Arak
Postal code
Phone
+98 86 3417 3545
Fax
Email
m.karimikia@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mansoreh Karimikia
Position
Student of Master of Sciences
Other areas of specialty/work
Street address
Sardasht Sq.
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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