Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573567
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Bioimpedance Analysis for Hemodialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Target Weight Guided by Bioimpedance Analysis in Hemodialysis Patients
Status:
NOT_YET_RECRUITING
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:
The goal of this clinical trial is to learn if bioimpedance-guided fluid management can help decrease hemodialysis complications The main questions it aims to answer are
Does bioimpedance-guided fluid management decrease major cardiovascular events Does bioimpedance-guided fluid management decrease other hemodialysis complications
Participants will
Take bioimpedance analysis once per month Adjust dry weight according to the analysis as possible in active group Blind the analysis results to the doctor and the patient in the control group
Does bioimpedance-guided fluid management decrease major cardiovascular events Does bioimpedance-guided fluid management decrease other hemodialysis complications
Participants will
Take bioimpedance analysis once per month Adjust dry weight according to the analysis as possible in active group Blind the analysis results to the doctor and the patient in the control group
Detailed Description:
The goal of this clinical trial is to learn if bioimpedance-guided fluid management can decrease major adverse cardiovascular events MACE symptoms during hemodialysis or other important outcomes such as vascular access patency fluid overload admissions etc in maintenance hemodialysis patients The main questions it aims to answer are
Hypothesis 1 bioimpedance-guided fluid management decreases MACE Hypothesis 2 bioimpedance-guided fluid management decreases intradialytic hypotension cramps and fatigue Hypothesis 3 bioimpedance-guided fluid management decreases need for urgent revascularization of vascular access for hemodialysis
Participants in the control group will decide their target weight according to physicians suggestion and the patients preference according to symptoms that are thought related to fluid status aberrancy for example edema crackles for fluid overload and cramps intradialytic hypotension fatigue for fluid insufficiency given no other acute illness accountable for the symptoms and intradialytic weight gain not exceeding 5 of previous weight
Participants in the active bioimpedance group will adjust their dry weight as those in the control group if symptoms of fluid status aberrancy present However if no symptoms occur they will receive adjustment according to measurements by bioimpedance analysis
Hypothesis 1 bioimpedance-guided fluid management decreases MACE Hypothesis 2 bioimpedance-guided fluid management decreases intradialytic hypotension cramps and fatigue Hypothesis 3 bioimpedance-guided fluid management decreases need for urgent revascularization of vascular access for hemodialysis
Participants in the control group will decide their target weight according to physicians suggestion and the patients preference according to symptoms that are thought related to fluid status aberrancy for example edema crackles for fluid overload and cramps intradialytic hypotension fatigue for fluid insufficiency given no other acute illness accountable for the symptoms and intradialytic weight gain not exceeding 5 of previous weight
Participants in the active bioimpedance group will adjust their dry weight as those in the control group if symptoms of fluid status aberrancy present However if no symptoms occur they will receive adjustment according to measurements by bioimpedance analysis
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