Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547697
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
DIALYSATE SODIUM CONCENTRATION AND BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EFFECT OF DIFFERENT DIALYSATE SODIUM CONCENTRATIONS ON BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
While hypertension is one of the most common causes of end-stage renal disease it is also present in the vast majority of hemodialysis patients It is associated with higher cardiovascular morbidity and mortality in this group of patients Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management However the ideal dialysate sodium concentration remains a topic for discussion
Randomised and prospective single dialysis centre study is presented The participants are randomly divided into 3 groups and will go through 3 periods of 2 months A low-to-high dialysate sodium concentration group will start the study with 138 mmolL in the first period continue with 140 mmolL in the second period and finish with 142 mmolL In the high-to-low group the participants will go through the opposite design reduction from 142 mmolL to 138 mmolL over 3 periods One group will continue with 140 mmolL throughout the study Systolic and diastolic BP values before and after dialysis sessions interdialytic weight gain ultrafiltration serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated
Randomised and prospective single dialysis centre study is presented The participants are randomly divided into 3 groups and will go through 3 periods of 2 months A low-to-high dialysate sodium concentration group will start the study with 138 mmolL in the first period continue with 140 mmolL in the second period and finish with 142 mmolL In the high-to-low group the participants will go through the opposite design reduction from 142 mmolL to 138 mmolL over 3 periods One group will continue with 140 mmolL throughout the study Systolic and diastolic BP values before and after dialysis sessions interdialytic weight gain ultrafiltration serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: