To determine the effect of propolis on rate of peritonitis due to catheter in continuous peritoneal dialysis.
Design
Clinical Trial, by using block randomization, the Patients enter in intervention, control, or placebo group. Parallel groups, double blind.
Settings and conduct
A study is conducted in Tehran's Shafa Hospital. Propolsis ointment is provided as a blind to a dialyser. Also the data analyst is blind. The patient will be assessed every two weeks for peritoneal dialysis. Monthly and with signs of infection and peritonitis, the culture of the catheter exit site and the dialysis output fluid will be sent for 6 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-60 years; at least history of three months peritoneal dialysis; lack of acute infections; at least 2-4 sessions of peritoneal dialysis per day; and lack of history of hypersensitivity to honey. Exclusion criteria: Other infections; catheter exit site infection; tunnel infection or peritonitis in the previous month; antibiotic therapy in the past four weeks; carriers of staphylococcus aureus; history of psychiatric illness and cognitive disorder.
Intervention groups
Intervention group: Every other day; in the morning after the dialysis the site of the catheter is washed with 0.9% normal saline and then 10% of the propolis ointment is used for 6 months. Control group: Every other day; in the morning after the dialysis the site of the catheter is washed with 0.9% normal saline and then 2% Mupirocin ointment is used for 6 months. In the placebo group: The catheter site was rinsed with 0.9% normal saline for 6 months.
Main outcome variables
Peritonitis is evaluated in the presence of Cloudy fluid, abdominal pain, white blood cell count of more than 100/ mm3 (at least 50% neutrophils), fever, and positive fluid dialysis culture.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110427006318N10
Registration date:2019-01-17, 1397/10/27
Registration timing:prospective
Last update:2019-01-17, 1397/10/27
Update count:0
Registration date
2019-01-17, 1397/10/27
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of propolis on the incidence of peritonitis in patients on continuous ambulatory peritoneal dialysis
Public title
The effect of propolis on the incidence of peritonitis in patients on continuous ambulatory peritoneal dialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-60 years
At least history of three months peritoneal dialysis
Lack of acute infections
At least 2-4 sessions of peritoneal dialysis per day
Lack of history of hypersensitivity to honey
Exclusion criteria:
Other sites of infections
Catheter exit site infection
Tunnel infection or peritonitis in the previous month
Antibiotic therapy over the past four weeks
Carriers of staphylococcus aureus
History of psychiatric illness
Cognitive disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample assigned to the groups of the study by permuted blocks randomization. Also blocking is used within age and frequency of dialysis during the day strata.
Blinding (investigator's opinion)
Double blinded
Blinding description
Propolsis ointment is provided as a blind to a dialyser. Also the data analyst is blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical sciences
Street address
Semnan University of Medical Sciences, Basij Blv, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
Ir.SEMUMS.REC.1397.200
Health conditions studied
1
Description of health condition studied
Peritonitis
ICD-10 code
K65.0
ICD-10 code description
Generalized (acute) peritonitis
Primary outcomes
1
Description
Peritonitis is evaluated in the presence of Cloudy fluid, abdominal pain, white blood cell count of more than 100/ mm3 (at least 50% neutrophils), fever, and positive fluid dialysis culture.
Timepoint
The patient will be assessed every two weeks for peritoneal dialysis. An aliquot of peritoneal effluent and a swab of exit site will be sent for culture monthly and in occasion of appearance of exit site secretion or peritonitis. The duration of assessment will continue for 6 months.
Method of measurement
Symptoms of peritonitis are evaluated according to the International Society for Peritoneal Dialysis (ISPD) criteria.
Secondary outcomes
1
Description
Exit site of catheter and tunnel are monitored for signs of infection (redness, pain, warmness and swelling, secretion from the exit site of the catheter).
Timepoint
The patient will be assessed every two weeks for infection signs. Monthly and with signs of infection and peritonitis, the culture of the catheter exit site and the dialysis output fluid will be sent for 6 months.
Method of measurement
Inspection of redness, pain, warmness and swelling, secretion from the exit site of the catheter
Intervention groups
1
Description
Intervention group: Every other day; in the morning after the dialysis the site of the catheter is washed with 0.9% normal saline and then 10% of the propolis ointment is used for 6 months.
Category
Prevention
2
Description
Control group: Every other day; in the morning after the dialysis the site of the catheter is washed with 0.9% normal saline and then 2% Mupirocin ointment is used for 6 months.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Monir Nobahar
Street address
Semnan, University of Medical Sciences, Nursing and Midwifery
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nobahar43@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blv, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
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
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan, University of Medical Sciences, Nursing and Midwifery
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan, University of Medical Sciences, Nursing and Midwifery
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan, University of Medical Sciences, Nursing and Midwifery
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data is confidential.
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data is confidential.
When the data will become available and for how long
It was possible to publish the paper from the study.
To whom data/document is available
Research group
Under which criteria data/document could be used
After publishing the resulting paper, it can be made available to others in order to use the results of the study.
From where data/document is obtainable
An article published in an valid journal among available journals
What processes are involved for a request to access data/document
The process of publishing an article in the journal