An observational study in Acute Kidney Injury, sponsored by University of Hertfordshire. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by University of Hertfordshire · Observational
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.
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 120 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Hertfordshire is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
A patient admitted into hospital that has an acute kidney injury within the first 72 hours of admission.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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).
Device: 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).
Also known as: Bioimpedance
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.
Time frame: Within 72 hours of admission
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.
Time frame: 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.
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
To identify descriptive data from the patients medical notes.
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.
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.
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
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.
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)
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.
Time frame: At 30 days after admission
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Aug 2026, 46 months after the start.
Of 349 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 46 months is above that.
Counting every sponsor, half of 364 studies reached it within 24 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Hertfordshire