We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05538351
Recruitment Status : Not yet recruiting
First Posted : September 13, 2022
Last Update Posted : September 13, 2022
Sponsor:
Collaborator:
East and North Hertfordshire NHS Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Kidney Injury Device: Body Composition Monitor (BCM)

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
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)
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Natalie Pattison 0745322056 natalie.pattison@nhs.net
Contact: Karen Nagalingam 07853170575 k.l.nagalingam@herts.ac.uk

Sponsors and Collaborators
University of Hertfordshire
East and North Hertfordshire NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Natalie Pattison East and North Herts
Layout table for additonal information
Responsible Party: University of Hertfordshire
ClinicalTrials.gov Identifier: NCT05538351    
Other Study ID Numbers: HSK/PGR/NHS/02973
First Posted: September 13, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Hertfordshire:
dehydration
hypotension
Acute Kidney Injury
hypovolaemia
respiratory rate
extracellular fluid
hypertension
body weight changes
pulmonary oedema
oedema
signs and symptoms
blood volume
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases