To determine the effect of dialysate temperature on adequacy of hemodialysis
Design
A two arm, parallel group, randomized trial to be carried out on minimum 50 patients at a single center. Randomization will be computerized with concealment using opaque envelopes.
Settings and conduct
This trial would be conducted at Dialysis Unit of Pak Emirates Military Hospital. Patients would be selected by non-probability convenience sampling. Randomization would be through computer generated sequences and would be concealed in opaque envelopes. Patients would undergo haemodialysis with dialysate temperature at 37.0 or 36.0 degree Celsius. They would be blinded to the treatment strategy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients on maintenance haemodialysis for at least 3 months;
Use of arteriovenous fistula
Exclusion criteria:
Acute kidney injury;
History of intradialytic hypotension during last one month;
Shortening of haemodialysis session for any reason;
Interruption in haemodialysis session for more than 5 minutes;
Patients known to have central venous stenosis;
Uncooperative patients;
Lack of consent
Intervention groups
Intervention group 1: Dialysate Temperature 37.0 degree Celsius. Patients in this group would have the dialysate temperature set at 37.0 degree Celsius when the machine is being setup for a dialysis session and maintained throughout the 4 hours session.
Intervention group 2: Dialysate Temperature 36.0 degree Celsius. Patients in this group would have the dialysate temperature set at 36.0 degree Celsius when the machine is being setup for a dialysis session and maintained throughout the 4 hours session.
Ultrafiltration would be done to the usual dry weight. All sessions would be carried out on Fresenius F4008 haemodialysis machines.
Comparison of the effects of different dialysate temperatures on adequacy of haemodialysis in patients with end stage renal disease
Public title
Effect of dialysis fluid temperature in haemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients on maintenance haemodialysis for at least 3 months
Use of arteriovenous fistula for haemodialysis
Exclusion criteria:
Acute kidney injury
History of intradialytic hypotension during last one month
Shortening of haemodialysis session for any reason
Interruption in haemodialysis session for more than 5 minutes
Patients known to have central venous stenosis
Uncooperative patients
Lack of consent
Age
From 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization would be done using computer generating sequencing. This would be done using online tools (calculator.net website). This would then be concealed in opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients and their caregivers would be blinded to the dialysate temperature, since this is set by the dialysis technicians and the patients are not aware of these settings. This parameter would not be visible on the display panel of the machines during the haemodialysis sessions, and would thus remain concealed from the patients
It would not be possible to blind the paramedical staff carrying out the dialysis sessions. However, they would have no role in data collection or analysis. Similarly, the principal investigator and two other doctors involved in data collection would not be blinded to the treatment groups. Since the outcome measures for this study are objective laboratory parameters, this lack of blinding is not expected to have a significant impact on the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Pak Emirates Military Hospital
Street address
The Mall Road
City
Rawalpindi
Postal code
46000
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
A/28/EC/1/24
Health conditions studied
1
Description of health condition studied
End-stage Renal Disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Urea reduction ratio
Timepoint
At the start and end of haemodialysis session
Method of measurement
Laboratory testing for serum urea levels
2
Description
Online Kt/V
Timepoint
During the four hours haemodialysis session
Method of measurement
Online Clearance Monitoring module of Fresenius F4008 machines
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Dialysate Temperature 37.0 degree Celsius. Patients in this group would have the dialysate temperature set at 37.0 degree Celsius when the machine is being setup for a dialysis session. The same temperature of dialysate would be maintained throughout the session of 4 hours duration. Ultrafiltration would be done to the usual dry weight.
Category
Treatment - Other
2
Description
Intervention group 2: Dialysate Temperature 36.0 degree Celsius. Patients in this group would have the dialysate temperature set at 36.0 degree Celsius when the machine is being setup for a dialysis session. The same temperature of dialysate would be maintained throughout the session of 4 hours duration. Ultrafiltration would be done to the usual dry weight.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak Emirates Military Hospital
Full name of responsible person
Altaf Hussain
Street address
The Mall Road
City
Rawalpindi
Postal code
46000
Phone
+92 302 5757487
Email
altafhussainafridi8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Altaf Hussain
Street address
The Mall Road
City
Rawalpindi
Postal code
46000
Phone
+92 302 5757487
Email
altafhussainafridi8@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital
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
Pak Emirates Military Hospital
Full name of responsible person
Altaf Hussain
Position
Postgraduate Resident
Latest degree
Bachelor
Other areas of specialty/work
Resident Internal medicine
Street address
The Mall Road
City
Rawalpindi
Province
Punjab
Postal code
4600
Phone
+92 302 5757487
Email
altafhussainafridi8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Altaf Hussain
Position
Postgraduate Resident
Latest degree
Bachelor
Other areas of specialty/work
Internal medicine
Street address
The Mall Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 302 5757487
Email
altafhussainafridi8@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospial
Full name of responsible person
Altaf hussain
Position
Postgraduate Resident
Latest degree
Bachelor
Other areas of specialty/work
Internal medicine
Street address
The Mall Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 302 7575487
Email
altafhussainafridi8@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
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
Title and more details about the data/document
When the data will become available and for how long
To whom data/document is available
Under which criteria data/document could be used
From where data/document is obtainable
What processes are involved for a request to access data/document