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NCT05869656Completed

THIRST Alert Trial

THIRST Alert Trial - a Randomised Controlled Trial Within the Electronic Health Record of an Interruptive Alert Displaying a Fluid Restriction Suggestion in Patients With the Treatable Trait of Congestion

Source: ClinicalTrials.gov · Last updated 6 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
23 (actual)
First submitted
26 Apr 2023
Start date
May 2023
Primary completion date
Nov 2023
Lead sponsor
University College, London
NCT number
NCT05869656

What you commit to

  • Study type: Interventional
  • Participants enrolled: 23
  • From May 2023 to the primary completion date, Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • On a surgical, obstetric or critical care ward environment

Other

  • Patients who opt out of study

Who the study is looking for

  • Prescribed IV furosemide during the first 48h of their admission as a regular prescription rather than a one-off dose.
  • Assessed as being suitable for inclusion in the trial by the responsible clinical team i.e., fluid restriction deemed to be in equipoise.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.