Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05538351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2022-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Sponsor:
University of Hertfordshire
Organization:
Study Overview
Official Title:
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
Acute Kidney Injury (AKI) is the sudden and recent reduction in kidney function. This can be detected by measuring a rise in blood creatinine level or from a reduction in urine. Reasons for developing AKI, include dehydration, low blood pressure, medication and infection. When the kidneys stop working, there can be a build-up of toxins and fluid. It is extremely important to identify a patient's fluid status as too little can cause further damage to the kidneys and too much can be harmful. Assessment is varied and often inaccurate and there needs to be a standard approach to fluid assessment.
Detailed Description:
Acute Kidney Injury (AKI) is the sudden and recent reduction in kidney function. This can be detected by measuring a rise in blood creatinine level or from a reduction in urine. Reasons for developing AKI, include dehydration, low blood pressure, medication and infection. When the kidneys stop working, there can be a build-up of toxins and fluid. It is extremely important to identify a patient's fluid status as too little can cause further damage to the kidneys and too much can be harmful. Assessment is varied and often inaccurate and there needs to be a standard approach to fluid assessment.
Aim:
To develop an Enhanced Fluid Assessment Tool for patients with AKI.
Workstream 1:
Aim: To identify what methods are useful to assess fluid in a patient with AKI. The fluid assessment techniques that are useful and are used, bioimpedance and patient reported signs and symptoms.
Workstream 2:
Aim: To identify the best methods of determining fluid status in a patient with AKI The findings from Workstream 1 will be used to rank the most useful fluid assessment techniques. This will lead to the development of the enhanced fluid assessment tool.
Workstream 3:
Aim: To assess if the tool is practical and clinically useful in determining a patient's fluid status.
The terminology and language will be reviewed and the tool will be used to assess patients and to determine the patients fluid status.
Aim:
To develop an Enhanced Fluid Assessment Tool for patients with AKI.
Workstream 1:
Aim: To identify what methods are useful to assess fluid in a patient with AKI. The fluid assessment techniques that are useful and are used, bioimpedance and patient reported signs and symptoms.
Workstream 2:
Aim: To identify the best methods of determining fluid status in a patient with AKI The findings from Workstream 1 will be used to rank the most useful fluid assessment techniques. This will lead to the development of the enhanced fluid assessment tool.
Workstream 3:
Aim: To assess if the tool is practical and clinically useful in determining a patient's fluid status.
The terminology and language will be reviewed and the tool will be used to assess patients and to determine the patients fluid status.
Study Oversight
Has Oversight DMC:
False
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?: