The present study aims to compare permanent hemodialysis recirculation with fixed tip and split tip catheters in chronic renal failure patients who attend Kermanshah Imam Reza hospital. It is a single blind clinical study. 164 patients were randomly selected and divided to two experiment groups. In both groups, after prep and drep the patients and creating proper position in neck extension, internal Jugular vein is found at bifurcation of Sternocleidomastoid muscle in Supraclavicular triangle toward Niple at the same side with needle guide. In the first group the main needle of fixed tip catheter set will be placed on the needle and in the second group the main needle of split tip catheter will be on the needle. Dialysis will be ceased 30 minutes later at optimal flow 250ml/m. Simultaneously, three blood samples are taken from artery and venous dialysis and also upper extremity vein opposite to catheter embedding. Samples are sent to laboratory to be tested for their urea levels and dialysis continues. Finally, considering the urea level in blood, blood recirculation is measured using three needle method and two groups are compared on their urea levels. Inclusion: written consent to attend the study by patients; patients with renal failure requiring hemodialysis; age of 16 to 70. Exclusion: patients who experienced central vein catheter. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031214333N30
Registration date:2015-05-07, 1394/02/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-07, 1394/02/17
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing permanent hemodialysis recirculation with fixed tip and split tip catheters in chronic renal failure patients
Public title
Study of two types of Permanent Hemodialysis Recirculation in Fixed Tip and Split Tip Catheters in chronic renal failure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: written consent to attend the study by patients; patients with renal failure requiring hemodialysis; age of 16 to 70. Exclusion: patients who experienced central vein catheter.
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-07-01, 1393/04/10
Ethics committee reference number
420/7/پ/13765
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Venous blood urea rate
Timepoint
30 minutes after staring dialysis
Method of measurement
Through laboratory
2
Description
Arterial blood urea rate
Timepoint
30 minutes after staring dialysis
Method of measurement
Through laboratory
3
Description
Peripheral blood urea rate
Timepoint
30 minutes after staring dialysis
Method of measurement
Through laboratory
4
Description
Recirculation of blood
Timepoint
Finishing the dialysis
Method of measurement
Based on the formula {(p-a)(p-v)}*100
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, after prep and drep the patients and creating proper position in neck extension, internal Jugular vein is found at bifurcation of Sternocleidomastoid muscle in Supraclavicular triangle toward Niple at the same side with needle guide. The main needle of fixed tip catheter set will be placed on the needle Dialysis will be ceased 30 minutes later at optimal flow 250ml/m. Simultaneously, three blood samples are taken from artery and venous dialysis and also upper extremity vein opposite to catheter embedding. Samples are sent to laboratory to determine their urea levels and dialysis resumes. Finally, considering the urea level in blood, blood recirculation is measured using three needles method.
Category
Treatment - Other
2
Description
In the second groups, after prep and drep the patients and creating proper position in neck extension, internal Jugular vein is found at bifurcation of Sternocleidomastoid muscle in Supraclavicular triangle toward Niple at the same side with needle guide. In the second group the main needle of split tip catheter set will be on the needle. Dialysis will be ceased 30 minutes later at optimal flow 250ml/m. Simultaneously, three blood samples are taken from artery and venous dialysis and also upper extremity vein opposite to catheter embedding. Samples are sent to laboratory to determine their urea levels and dialysis continues. Finally, considering the urea level in blood, blood recirculation is measured using three needles method. .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza Hospital
Full name of responsible person
Dr. Mahmood Rasekhi
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ezatollah Sadeghi
Position
Vascular Surgery
Other areas of specialty/work
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
Ezatollahsadeghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)