A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury

NCT05538351 | Active Not Recruiting

• 1 other identifier: HSK/PGR/NHS/02973
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Within 72 hours of admission

• To identify patient-focussed signs and symptoms of hydration in AKI

  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

  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.

  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

  At 30 days since admission

Study Arms (1)

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).

Device: Body Composition Monitor (BCM)

Interventions

Body Composition Monitor (BCM) DEVICE

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

Fluid assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hertfordshire: lead
• East and North Hertfordshire NHS Trust: collaborator

Study Sites (1)

East and North Hertfordshire NHS Trust, Lister Hospital

Stevenage, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney Injury; Dehydration; Hypotension; Hypovolemia; Hypertension; Body Weight Changes; Pulmonary Edema; Edema; Signs and Symptoms

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Body Weight; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Natalie Pattison

  East and North Herts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)