A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
- Conditions
- Acute Kidney Injury
- Interventions
- Device: Body Composition Monitor (BCM)
- Registration Number
- NCT05538351
- Lead Sponsor
- University of Hertfordshire
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fluid assessment 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).
- Primary Outcome Measures
Name Time Method To identify the components of clinical assessment deemed useful in determining fluid status in patients with AKI. 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.
- Secondary Outcome Measures
Name Time Method To evaluate whether fluid status of patients is related to: Stage of AKI, Cause of AKI, Length of stay, NEWS2 Measurements At 30 days after admission To identify descriptive data from the patients medical notes.
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) At 30 days after admission 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.
To identify fluid status of patients with AKI using multiple assessments, including Bioimpedance, objective and subjective clinical assessments. Within 72 hours of admission Bioimpedance measures fluid status and location of this fluid within the body.
To identify patient-focussed signs and symptoms of hydration in AKI Within 72 hours of admission The patient with acute kidney injury will be asked to describe their signs and symptoms relating to acute kidney injury.
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. Within 72 hours of admission 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.
To evaluate whether fluid status is related to: Fluid balance chart/ trends and documentation (positive or negative balance) , Weight trends, Charlson Co-morbidity index At 30 days since admission 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.
Trial Locations
- Locations (1)
East and North Hertfordshire NHS Trust, Lister Hospital
🇬🇧Stevenage, United Kingdom