The use of bicarbonate high-dialysis to improve the physical and biochemical indexes of nutritional status in dialysis patients
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The study will be carried out in the hemodialysis department of the Persian Gulf Hospital in Bushehr.
To avoid orientation in the study, we attempt to double-blind blindness. The first group is either participants or patients, and the second group is statistical advisers who will analyze the data. Therefore, patients will not be aware of the fact that they are in the case or control group.Also, the information in the case and control groups is named as Groups A and B and given to statistical consultants.
Participants/Inclusion and exclusion criteria
Entry Criteria:
They have been under hemodialysis for at least 3 months
Patients who are able to stand on the body composition
Non-Entry Criteria:
base HCO3 in ABG above 24
kt/v<1/2 ، Ca < 5/7 و K < 5/3
Intervention groups
Intervention group: use of dialysis fluid with bicarbonate 36
Control group: use of dialysis fluid with bicarbonate 32 (Standard and Common)
Main outcome variables
Body Mass Index, Albumin, Calcium, Phosphorus, Sodium, Potassium, HsCRP, TNF, PTH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190130042563N1
Registration date:2019-06-30, 1398/04/09
Registration timing:retrospective
Last update:2019-06-30, 1398/04/09
Update count:0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Farnaz Hefzollah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3354 3581
Email address
dr.ammarbasri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of bicarbonate high-dialysis on Body Mass Index, ABG, Albumin, Inflammation Indexes and Blood nutritional indexes in dialysis patients
Public title
Effect of bicarbonate high-dialysis on Body Mass Index, ABG, Albumin, Inflammation Indexes and Blood nutritional indexes in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They have been under hemodialysis for at least 3 months
Patients who are able to stand on the body composition
Exclusion criteria:
base HCO3 in ABG above 24
kt/v<1/2 ، Ca < 5/7 و K < 5/3
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize, table of numbers will be used, with the pair numbers are control group and the individual numbers are the case group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Will not be told to patients that they are in the case or control group. Also, the data of the case and control groups are named as Groups A and B and given to statistical advisers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Bushehr university of Medical Science, Rishehr Ave., Salmane Farsi Blvd., Bahmani Town
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.DCUMS.REC.1397.115
Health conditions studied
1
Description of health condition studied
end-stage renal disease (ESRD)
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
High Sensitive C reactive Protein
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
HS-CRP monobind kit
2
Description
TNF-a
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
TNF-a kit
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
Body Composition
2
Description
Albumin
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
Albumin kit
3
Description
Blood level of phosphorus
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
Phosphorus Measuring Kit
4
Description
Blood level of Calcium
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
Calcium Measuring Kit
5
Description
Blood level of sodium
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
Sodium Measuring Kit
6
Description
Blood level of Potassium
Timepoint
Before the intervention and the end of the study (after 6 months)
Method of measurement
Potassium Measuring Kit
Intervention groups
1
Description
Intervention group: Hemodialysis with high bicarbonate (36)
Category
Treatment - Other
2
Description
Control group: Hemodialysis with common bicarbonate
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Khalije Fars Hospital
Full name of responsible person
Mehdi Mahmoudpour
Street address
Taleghani Blvd., Azadi square
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5375
Email
mpgh@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
ِDeputy of Research and Technology- Dr Gholamreza Khamisipour
Street address
Rishehr ave., Salmane Farsi Blvd., Bahmani Town
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0236
Email
bpums@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Farnaz Hefzollah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shohadaye Khalij Fars Hospital, Taleghani Boulevard, Azadi square
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5374
Email
hefzollahf@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mehdi Mahmoudpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shohadaye Khalij Fars Hospital, Taleghani Boulevard, Azadi square
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5374
Email
mehdimpr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Farnaz Hefzollah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shohadaye Khalij Fars Hospital, Taleghani Boulevard, Azadi square
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5374
Email
hefzollahf@yahoo.co.uk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available