Evaluation of femoral tunnel hemodialysis catheter efficacy with different sizes
Design
This study is clinical trial and double blind.50 patients candidate hemodialysis in amiralmomenin hospital will inter this study.We will divide patients in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.50 patients candidate hemodialysis in Valiasr hospital will inter this study.Outcome assessor and analyzer not aware from grouping.Codes of group are available to analyzer and outcome assessor.Function and catheter effects are checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria:There were no patients with the possibility of insertion of intravenous arteriovenous fistula or the possibility of insertion of Jugular and Subclavian Premium Catheter in the central vein catheterization , embedded candidate access hemodialysis of the lower limb
Exclusion criteria: The history of catheterization from femoral area or deep vein thrombosis in the lower extremity
Intervention groups
We put in one group 35 centimeter dialysis catheter and in another group we put 42 centimeter dialysis catheter
Main outcome variables
Function and complications of catheter types
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130410012973N3
Registration date:2019-05-13, 1398/02/23
Registration timing:registered_while_recruiting
Last update:2019-05-13, 1398/02/23
Update count:0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Amirreza Naimi
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 1041
Email address
naimi-a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of femoral tunnel hemodialysis catheter efficacy with different sizes
Public title
Evaluation of efficiency of dialysis tube of thigh with different sizes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who cant put arteriovenous fistula or Jugular and subclavian catheters
Exclusion criteria:
The history of catheterization from femoral area or deep vein thrombosis in the lower extremity
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Valiasr sq.
City
َArak
Province
Markazi
Postal code
3814957558
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.ARAKMU.REC.1397.305
Health conditions studied
1
Description of health condition studied
End stage renal disese
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure
Primary outcomes
1
Description
Function and complication of different catheter
Timepoint
1 and 3 and 6 months after insertion catheter
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We put in a group a 35 centimeter dialysis catheter in femur (Bared.co).
Category
Treatment - Surgery
2
Description
Intervention group: We put in a group a 42 centimeter dialysis catheter in femur(Bared.co).