Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358820
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-07
Brief Title:
Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
Sponsor:
The Peoples Hospital of Gaozhou
Organization:
The Peoples Hospital of Gaozhou
Study Overview
Official Title:
Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients a Multicenter Open Prospective Self Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study adopts a multicenter open prospective and self controlled study design in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the studyBefore treatment and during the 3rd and 6th months of treatment subjects were evaluated for various efficacy and safety indicators and any adverse or serious adverse events were recorded
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None