Ignite Creation Date:
2024-05-06 @ 9:32 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03004547
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2016-12-16
Brief Title:
Sodium Deposition in Soft Tissues of Patients With Kidney Disease
Sponsor:
Chris McIntyre
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Evaluation of Sodium Deposition in Soft Tissues of Patients With Kidney Disease and Its Association With Patient Symptomatology
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sodium Na hemostasis is abnormal in CKD patients and this element can be deposited in the skin muscle and skeleton - to cope with long term sodium loading It is known that sodium stored in this non-osmotically active way is profoundly inflammatory Furthermore inflammation has been associated with several uremic symptoms The investigators will use novel Na MRI imaging to examine the Na deposition in the skin muscle and skeleton of five groups1 chronic in-center hemodialysis patients 2 chronic peritoneal dialysis patients 3 adult and paediatric patients with CKD stage 1-5 and 4 heart failure patients with and without renal dysfunction 5 sex and age-matched healthy adult and paediatric controls Additionally they will investigate the association between sodium deposition in these tissues with uremic symptomatology and biochemical markers of metabolism
Detailed Description:
Kidneys have a key role in sodium hemostasis through their excretory function In patients with chronic kidney disease CKD kidney function is impaired thus suggesting that sodium handling is abnormal in this setting with long-term sodium loading from oral intake and lack of adequate urinary excretion Yet sodium concentration needs to stay relatively constant to prevent fatal intra-cellular accumulation which would result in cell injury and death In hemodialysis patients at least a part of this extra sodium is non-osmotically active and deposited in the skin muscle and skeleton
Furthermore it has become increasingly recognized that sodium once accumulated in tissues is directly pro-inflammatory affecting the innate immune system by regulating the activity of macrophages in skin This linkage between sodium and inflammation indicates a potential link between sodium deposition and uremic symptoms experienced by patients
There have been no studies to date examining the sodium deposition in the skin muscle and skeleton of patients with different kidney function and renal replacement therapy
This is a pilot study involving a single center recruiting patients from the prevalent maintenance hemodialysis peritoneal dialysis CKD stage 1-5 and heart failure populations of London Ontario compared to healthy controls Once recruited participants will undergo one study visit with the potential of up to two follow-up visits on a non-dialysis day for hemodialysis patients Participants will be followed for up to two years after the first study visit Each session will include symptom questionnaires the five times sit to stand and 60-second chair stand test excluding all children blood pressure and heart rate measurements blood work excluding healthy children and adolescents urine sampling excluding those on dialysis an echocardiogram excluding healthy controls and an MRI scan of the lower leg detecting sodium content
Furthermore it has become increasingly recognized that sodium once accumulated in tissues is directly pro-inflammatory affecting the innate immune system by regulating the activity of macrophages in skin This linkage between sodium and inflammation indicates a potential link between sodium deposition and uremic symptoms experienced by patients
There have been no studies to date examining the sodium deposition in the skin muscle and skeleton of patients with different kidney function and renal replacement therapy
This is a pilot study involving a single center recruiting patients from the prevalent maintenance hemodialysis peritoneal dialysis CKD stage 1-5 and heart failure populations of London Ontario compared to healthy controls Once recruited participants will undergo one study visit with the potential of up to two follow-up visits on a non-dialysis day for hemodialysis patients Participants will be followed for up to two years after the first study visit Each session will include symptom questionnaires the five times sit to stand and 60-second chair stand test excluding all children blood pressure and heart rate measurements blood work excluding healthy children and adolescents urine sampling excluding those on dialysis an echocardiogram excluding healthy controls and an MRI scan of the lower leg detecting sodium content
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None