The Rhabdomyolysis Evaluation in the Emergency Department (REED) Score

NCT07158554 | Recruiting

• 1 other identifier: IRAS Project ID: 362575
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

One in three adults over 65 fall annually, with one in five remaining on the floor for greater than one hour, which is referred to as a long lie. Pressure on the National Health Service has resulted in extended stays in the Emergency Department (ED) (sometimes longer than 12 hours) and prolonged ambulance response times. This impacts the older adults who have fallen and remain on the floor. This project aims to develop a risk prediction model (RPM) for use within the ED to understand which older adults (60 years or older) who fall over and remain on the floor for longer than one hour ("long lie") and develop rhabdomyolysis (a serious condition where muscle breaks down and releases substances into the blood that can damage the kidneys) will develop poor outcomes and need admission to hospital for treatment and which patients can be safely discharged home. Aim: To develop a RPM to identify which older adults who have a fall and a long lie and attend the ED develop poor outcomes such as Acute kidney Injury (AKI) \[kidneys suddenly stop working properly\], needing kidney replacement therapy (KRT) \[a treatment that helps kidneys that aren't working properly do their job of cleaning the blood\] and mortality \[death\]. Objectives:

1. 1.Abstract patient level data (e.g. biochemical, demographic, situational, medical history, medication history) from medical records combined with outcomes to understand which variables lead to poor outcomes such as AKI, needing KRT and mortality.
2. 2.Analyse the data using a statistical package (Statistical Package for Social Sciences \[SPSS\]) to develop a RPM with good discriminative abilities \[how well the score can tell high-risk from low-risk patients\].
3. 3.Demonstrate the ability of the RPM to identify which patients need admission to hospital with treatment and which patients can be safely discharged home.

Conditions

Rhabdomyolysis; Death; Kidney Replacement Therapy; Fall Patients; Acute Kidney Injury

Keywords

The REED Score; Rhabdomyolysis; Emergency Department; Long Lie

Outcome Measures

Primary Outcomes (3)

• Number of participants with an Acute Kidney Injury (AKI)

  AKI defined by the KDIGO criteria

  30 days

• Number of participants needing Kidney Replacement Therapy (KRT)

  The number of participants needing KRT within 30 days of the index event

  30 days

• The number of participants who die

  The number of participants who die within 30 days of the index event

  30 days

Study Arms (1)

Older Adults

Adults aged 60 or older who have a fall and remain immobilised for \>1 hour

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NHS Emergency Department in England

You may qualify if:

• years old or older at time of ED presentation
• Developed rhabdomyolysis (defined as CK \>999U/L)
• Have had a fall and been / suspected to have been on the floor / immobilised in one position for \> 59 minutes.

You may not qualify if:

• Patient opted out of research studies via the National Data Opt Out (NDOO) Service.
• Principal Investigator (PI) had clinical input into patient care.
• Other causes of elevated creatine kinase (e.g. seizures, acute coronary syndromes, burns, myositis, muscular dystrophy, cardiac arrest)

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: collaborator
• University of Salford: lead

Study Sites (1)

Southend University Hospital

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Rhabdomyolysis; Death; Acute Kidney Injury; Emergencies

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes

Study Officials

• Ashley Reed, MSc MResCP BSc (Hons)

  University of Salford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Reed, MSc MResCP BSc (Hons)

CONTACT

+447534964854; A.D.Reed@edu.salford.ac.uk

Study Design

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

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 7, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Likely available September 2027 - stored for 10 years, until Sept 2037
• Access Criteria: It will be anonymised and is open access to use for research purposes

Locations

GB (1)