Acute Kidney InjuryNCT05538351
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
An observational study of Acute Kidney Injury, run by University of Hertfordshire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Body Composition Monitor (BCM)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2022to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A patient admitted into hospital that has an acute kidney injury within the first 72 hours of admission.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East and North Hertfordshire NHS Trust, Lister Hospital
Stevenage
About this study
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.
Read the 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
- Being tested
- Body Composition Monitor (BCM)
- Keywords
- dehydration, hypotension, Acute Kidney Injury, hypovolaemia, respiratory rate, extracellular fluid, hypertension, body weight changes, pulmonary oedema, oedema, signs and symptoms, blood volume
- Medical subject headings
- Acute Kidney Injury, Dehydration, Hypotension, Hypovolemia, Hypertension, Body Weight Changes, Pulmonary Edema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Composition Monitor (BCM)Device
Also called Bioimpedance
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Body Composition Monitor (BCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the components of clinical assessment deemed useful in determining fluid status in patients with AKI.
Identifying the components of a volume assessment as defined in RCP (2015) Acute care toolkit and a scoping review on fluid assessment. Assessment includes; physiological parameters including blood pressure, weight changes, and physical examination, including identifying any signs of oedema or dehydration and history taking.
Measured: Within 72 hours of admission
Secondary outcomes (6)
To identify fluid status of patients with AKI using multiple assessments, including Bioimpedance, objective and subjective clinical assessments.
Bioimpedance measures fluid status and location of this fluid within the body.
Measured: Within 72 hours of admission
To identify patient-focussed signs and symptoms of hydration in AKI
The patient with acute kidney injury will be asked to describe their signs and symptoms relating to acute kidney injury.
Measured: Within 72 hours of admission
To evaluate whether fluid status of patients is related to: Stage of AKI, Cause of AKI, Length of stay, NEWS2 Measurements
To identify descriptive data from the patients medical notes.
Measured: At 30 days after admission
To evaluate whether fluid status of patients is related to: Physical assessment (JVP, oedema, skin, respiratory, lying and standing BP, passive leg raise), Blood results: urea and creatinine, electrolytes, albumin, haemoglobin and bicarbonate.
Comparison between patients in different fluid status groups will be compared using t-tests (or non-parametric comparisons), or Chi squared (χ2) tests. Multi variable models will be explored to evaluate the relationship of measured variables to fluid status using logistic models.
Measured: Within 72 hours of admission
To evaluate whether fluid status is related to: Fluid balance chart/ trends and documentation (positive or negative balance) , Weight trends, Charlson Co-morbidity index
A multivariate analysis of clinical characteristics (specifically as listed in the primary objective) to investigate their predictive effect for mortality at 30 days. Variables that are significant in univariate models at the 10% level will be then included in a multivariable regression analysis.
Measured: At 30 days since admission
To evaluate whether fluid status is related to: Outcome: Renal Replacement therapy (RRT) during admission/ Recovery of kidney / dialysis dependence at 30 days/ Intensive care admission • Mortality (hospital 30-days) • Readmission (within 30 days)
A multivariate analysis of clinical characteristics (specifically as listed in the primary objective) to investigate their predictive effect for mortality at 30 days. Variables that are significant in univariate models at the 10% level will be then included in a multivariable regression analysis.
Measured: At 30 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start9 Sep 2022
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hertfordshire
- Sponsor type
- University, hospital or other
- Collaborators
- East and North Hertfordshire NHS Trust
- Responsible party
- Sponsor
- Investigators
- Natalie Pattison, Principal investigator, East and North Herts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538351
- Sponsor's protocol ID
- HSK/PGR/NHS/02973
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05538351
- Acronym / sponsor ID
- HSK/PGR/NHS/02973
- Conditions
- Acute Kidney Injury
- Keywords
- dehydration, hypotension, Acute Kidney Injury, hypovolaemia, respiratory rate, extracellular fluid, hypertension, body weight changes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Collaborators
- East and North Hertfordshire NHS Trust
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid assessment | – | Device: Body Composition Monitor (BCM)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient admitted into hospital that has an acute kidney injury within the first 72 hours of admission.
Key inclusion criteria (6 listed)
- 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.
- 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.
- Phase 1: Experts in fluid assessment (Doctors, Nurses and AHPs). Phase 2: Staff nurses currently working on a clinical ward.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Composition Monitor (BCM)Also: BioimpedanceThe 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). | Device | Fluid assessment |
Primary outcome
To identify the components of clinical assessment deemed useful in determining fluid status in patients with AKI.
Time frame: Within 72 hours of admission
Identifying the components of a volume assessment as defined in RCP (2015) Acute care toolkit and a scoping review on fluid assessment. Assessment includes; physiological parameters including blood pressure, weight changes, and physical examination, including identifying any signs of oedema or dehydration and history taking.
6 secondary outcomes
To identify fluid status of patients with AKI using multiple assessments, including Bioimpedance, objective and subjective clinical assessments.
Time frame: Within 72 hours of admission
To identify patient-focussed signs and symptoms of hydration in AKI
Time frame: Within 72 hours of admission
To evaluate whether fluid status of patients is related to: Stage of AKI, Cause of AKI, Length of stay, NEWS2 Measurements
Time frame: At 30 days after admission
To evaluate whether fluid status of patients is related to: Physical assessment (JVP, oedema, skin, respiratory, lying and standing BP, passive leg raise), Blood results: urea and creatinine, electrolytes, albumin, haemoglobin and bicarbonate.
Time frame: Within 72 hours of admission
To evaluate whether fluid status is related to: Fluid balance chart/ trends and documentation (positive or negative balance) , Weight trends, Charlson Co-morbidity index
Time frame: At 30 days since admission
To evaluate whether fluid status is related to: Outcome: Renal Replacement therapy (RRT) during admission/ Recovery of kidney / dialysis dependence at 30 days/ Intensive care admission • Mortality (hospital 30-days) • Readmission (within 30 days)
Time frame: At 30 days after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Pattison principal investigator
East and North Herts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University of Hertfordshire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the components of clinical assessment deemed useful in determining fluid status in patients with AKI. (time frame: Within 72 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.