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Impact of bladder irrigation with normal saline solution on the control of cystitis in the patients having urinary catheters in the Intensive Care Unit

Protocol summary

Summary
The present Single blind clinical trial will be conducted to determine the effects of bladder irrigation with normal saline on cystitis of catheterized patients in an Intensive Care Unit. 60 eligible patients will be randomly allocated to the experiment group (n=30) or control group (n=30). The inclusion criteria are: having urinary catheter, over 18 years old, suspected or asymptomatic bacteriuria induced by a urinary catheter. The exclusion criteria are: urinary catheter removal, patient's transfer or death, having chronic disease(Immunodeficiency, Diabetes mellitus, recurrent urinary tract infection before admission, anatomic problems and trauma to the to the genitourinary system, Chronic kidney disease, Acute or chronic glomerulonephritis, Pyelonephritis, the use of Aminoglycosides، laboratory observer willnot know about patients' groups. Both groups will receive the routine care and medications. But, the experiment patients will receive bladder irrigation with normal saline once a day for 3 days with 500 ml. in three doses of 150 ml.The primary outcomes:ESR, leukocytosis, nitrite, number and type of bacteria.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201702134578N6
Registration date: 2017-05-04, 1396/02/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-05-04, 1396/02/14
Registrant information
Name
Farshid Rahimibashar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 811264002151
Email address
f.rahimi@umsh.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of bladder irrigation with normal saline solution on the control of cystitis in the patients having urinary catheters in the Intensive Care Unit
Public title
Impact of bladder irrigation on the control of cystitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having urinary catheter, over 18 years old, suspected or asymptomatic bacteriuria induced by a urinary catheter exclusion criteria: urinary catheter removal due to physician order or spontaneous, patient's transfer or death, having chronic diseases (Immunodeficiency, Diabetes mellitus, recurrent urinary tract infection before admission, anatomic problems and trauma to the to the genitourinary system, Chronic kidney disease, Acute or chronic glomerulonephritis, Pyelonephritis, the use of Aminoglycosides.
Age
From 18 years old to 85 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized Block

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamedan
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.495

Health conditions studied

1

Description of health condition studied
cystitis
ICD-10 code
N30.2
ICD-10 code description
urinary tract infection,site not specified

Primary outcomes

1

Description
ESR
Timepoint
Before and After 3 days
Method of measurement
Vstrgryn

2

Description
Leukocytosis
Timepoint
Before and After 3 days
Method of measurement
Cell Blood Count

3

Description
Nitrite
Timepoint
Before and After 3 days
Method of measurement
Urinalysis

4

Description
Number Bacteria
Timepoint
Before and After 3 days
Method of measurement
Urine Culture

5

Description
Type of Bacteria
Timepoint
Before and After 3 days
Method of measurement
Urine Culture

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the experiment patients will receive bladder irrigation with normal saline once a day for 3 days with 500 ml. in three doses of 150 ml
Category
Prevention

2

Description
Control group: The control group will receivel care routine
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Farahnaz Ramezani
Street address
General ICU, BESAT Hospital, Motahhari boulevar, Resalat Square
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor
Other areas of specialty/work
Street address
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3264 0025
Fax
Email
f.rahimi@umsh.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor
Other areas of specialty/work
Street address
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square
City
Hamedan
Postal code
Phone
+98 912 581 6621
Fax
Email
f.rahimi@umsh.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Farahnaz Ramezani
Position
Masters student
Other areas of specialty/work
Street address
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square
City
Hamedan
Postal code
Phone
+98 81 3826 5702
Fax
Email
ramezanifarah@gmial.com
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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