THIRST Alert Trial

Summary

The aim of this feasibility study is to determine whether an alert embedded within the electronic health record (EHR) causes clinicians to enrol patients into a randomised controlled trial (RCT) comparing oral fluid restriction versus no restriction in patients admitted to hospital with fluid overload.

One of the main causes of fluid overload is heart failure where there is a lack of strong evidence to support the effectiveness of oral fluid restriction in the acute setting. This causes significant variation in clinical practice where decisions on whether or not to impose a restriction in oral fluid intake is based on the preference of the treating clinician rather than robust evidence from research.

THIRST Alert is a pragmatic randomised controlled trial (RCT), embedded in the EHR, which seeks to determine whether a computerised alert for the clinical team can change clinician behaviour during routine NHS care at University College London Hospitals NHS Foundation Trust (UCLH).

Patients with suspected fluid overload will be identified based on the prescription of intravenous furosemide, a medication used to stimulate diuresis (increased urine output) to remove excess fluid. A repeat prescription of intravenous furosemide within the first 48 hours of an unplanned admission will trigger the alert.

A clinician from the treating team will then be asked to consider enrolling the patient into the RCT if they judge that oral fluid restriction might be beneficial but they have uncertainty about this (clinical equipoise). Enrolled patients will be randomised to either oral fluid restriction of 1 litre per day or no fluid restriction. This will then be actioned through documenting as part of the clinical plan in the patients record and then communicated to the patient and the rest of the clinical team, including nursing staff.

The study will record the number of patients recruited into the trial and the effect of the alert on enrolled patients' subsequent oral fluid intake. There are no additional tests or follow up for patients and the trial finishes on discharge from the study site. All trial outcomes will use data collected from routine care and the study is supported by the UCLH Biomedical Research Centre, funded by NIHR.

Conditions

• Fluid Overload
• Congestive Heart Failure

Interventions

BEHAVIORAL

Fluid restriction

Oral fluid restriction of 1000ml per day

BEHAVIORAL

Free fluids

Continue care without any oral fluid restriction

Sponsors & Collaborators

• University College London Hospitals (UCLH) NHS Foundation Trust

  collaborator UNKNOWN

• National Institute for Health and Care Research (NIHR) UCLH Biomedical Research Centre

  collaborator UNKNOWN

• University College, London

  lead OTHER

Principal Investigators

• Yang Chen, BMBCh, MSc · UCL

• Tom Lumbers, MBBChir, PhD · UCL

• Anoop D Shah, MBBS, PhD · UCL

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-03

Primary Completion

2023-11-04

Completion

2023-12-04

Countries

• United Kingdom

Study Locations