Clinical trial NCT05538351: A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Official title: A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: dehydration
hypotension
Acute Kidney Injury
hypovolaemia
respiratory rate
extracellular fluid
hypertension
body weight changes
pulmonary oedema
oedema
signs and symptoms
blood volume
Lead sponsor: University of Hertfordshire
Sponsor class: OTHER
Collaborators: name: East and North Hertfordshire NHS Trust
First posted: 2022-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient admitted into hospital that has an acute kidney injury within the first 72 hours of admission.

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.

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

Primary outcomes:
measure: To identify the components of clinical assessment deemed useful in determining fluid status in patients with AKI.
timeFrame: Within 72 hours of admission
Secondary outcomes:
measure: To identify fluid status of patients with AKI using multiple assessments, including Bioimpedance, objective and subjective clinical assessments.
timeFrame: Within 72 hours of admission
measure: To identify patient-focussed signs and symptoms of hydration in AKI
timeFrame: Within 72 hours of admission
measure: To evaluate whether fluid status of patients is related to: Stage of AKI, Cause of AKI, Length of stay, NEWS2 Measurements
timeFrame: At 30 days after admission
measure: 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.
timeFrame: Within 72 hours of admission
measure: To evaluate whether fluid status is related to: Fluid balance chart/ trends and documentation (positive or negative balance) , Weight trends, Charlson Co-morbidity index
timeFrame: At 30 days since admission
measure: 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)
timeFrame: At 30 days after admission
Other outcomes:
Locations:
city: Stevenage
country: United Kingdom
facility: East and North Hertfordshire NHS Trust, Lister Hospital
Study officials:
affiliation: East and North Herts
name: Natalie Pattison
role: PRINCIPAL_INVESTIGATOR
References: