A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
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|ClinicalTrials.gov Identifier: NCT05538351|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2022
Last Update Posted : September 13, 2022
|Condition or disease||Intervention/treatment|
|Acute Kidney Injury||Device: Body Composition Monitor (BCM)|
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.
To develop an Enhanced Fluid Assessment Tool for patients with AKI.
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.
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.
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 Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury|
|Estimated Study Start Date :||September 9, 2022|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2025|
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).
Other Name: Bioimpedance
- 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.
- 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 ]Bioimpedance measures fluid status and location of this fluid within the body.
- To identify patient-focussed signs and symptoms of hydration in AKI [ Time Frame: 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: Stage of AKI, Cause of AKI, Length of stay, NEWS2 Measurements [ Time Frame: At 30 days after admission ]To identify descriptive data from the patients medical notes.
- 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 ]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 [ Time Frame: 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.
- 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 ]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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05538351
|Contact: Natalie Pattisonemail@example.com|
|Contact: Karen Nagalingamfirstname.lastname@example.org|
|Principal Investigator:||Natalie Pattison||East and North Herts|