A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury

NCT ID: NCT05538351

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2026-08-01

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fluid assessment

All patients enrolled in this study will have a clinical assessment to identify hydration status, patient reported signs and symptoms of hydration and Bioimpedance using the Body composition Monitor (BCM).

Body Composition Monitor (BCM)

Intervention Type: DEVICE

The hydration status of each participant from the clinical assessment and the patient reported signs and symptoms will be compared with the readings from bioimpedance (BCM machine).

Interventions

Body Composition Monitor (BCM)

The hydration status of each participant from the clinical assessment and the patient reported signs and symptoms will be compared with the readings from bioimpedance (BCM machine).

Intervention Type: DEVICE

Other Intervention Names

Bioimpedance

Eligibility Criteria

Inclusion Criteria

• Workstream 1 and 3 (phase 3):

Patients who will be included in the study will be Adult patients (over 18 years old) identified as having an acute kidney injury (AKI) within 72 hours of admission to hospital.

Workstream 2:

Experts in fluid assessment (Doctors, Nurses and AHPs). Persons included will be experts in their field of practice and have a recognised expertise in fluid assessment.

Workstream 3:

Phase 1: Experts in fluid assessment (Doctors, Nurses and AHPs). Phase 2: Staff nurses currently working on a clinical ward.

Exclusion Criteria

• Patients who have kidney failure requiring dialysis or who are being conservatively managed.
• Patients who are receiving end of Life (EoL) care.
• Patients who have a pacemaker as this interferes with bioimpedance (WS1+3).
• There is no baseline creatinine.
• The patient has acquired an AKI 72 hours after admission to hospital.
• The patient has acute coronary syndrome

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

East and North Hertfordshire NHS Trust

OTHER_GOV

Sponsor Role: collaborator

University of Hertfordshire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Pattison

Role: PRINCIPAL_INVESTIGATOR

East and North Herts

Locations

East and North Hertfordshire NHS Trust, Lister Hospital

Stevenage, , United Kingdom

Countries

United Kingdom

Other Identifiers

HSK/PGR/NHS/02973

Identifier Type: -

Identifier Source: org_study_id