RecruitingNot ApplicableNCT07173426

Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure


Sponsor

Mid and South Essex NHS Foundation Trust

Enrollment

255 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test whether using Bioimpedance Analysis (BIA) can help manage fluid levels in patients with heart failure who are admitted to the hospital with worsening symptoms. The main questions it aims to answer are: 1\. Does BIA-guided fluid management reduce the need for extra treatment (in the form of diuretics which helps remove excess fluid from the body) or re-hospitalization for heart failure within 90 days after discharge? Researchers will compare a group receiving BIA-guided treatment to a standard care group to see if BIA provides better results in managing fluid levels. Participants will be randomly assigned to one of two groups: BIA-Guided Treatment Group: Have BIA measurements done within 24 hours of admission and throughout their hospital stay to guide diuretic treatment. Standard Care Group: Have BIA measurements taken at admission and discharge, but the results will not be shared with the clinical team, who will manage fluid levels as usual. All patients will attend a follow-up visit in 2-4 weeks after discharge where the patient will undergo standard health checks, blood tests, and a questionnaire about how heart failure affects their quality of life. The investigators will then compare both groups for the primary outcome measure, which is the rates of rehospitalisation or need for additional decongestive treatment, within 90 days of discharge from hospital.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age \>18 years
  • Patients with hospitalised with a decompensated episode of Heart Failure regardless of Ejection Fraction
  • Able and willing to consent.

Exclusion Criteria5

  • Patients on a palliative care pathway and/or estimated life expectancy \<3 months
  • Patients admitted to ITU/ on intensive care support.
  • Patients currently taking part in any trials investigating new heart failure drug or interventional treatment.
  • Patients requiring Renal Replacement Therapy.
  • Patients unable or unwilling to give consent.

Interventions

DEVICEBioimpedance analysis

Bioimpedance analysis involves electrodes attached to the patient's limbs which measures the resistance in the body to an imperceptible high-frequency, low-amplitude alternating electrical current. BIA measurements will include total body water (TBW), intracellular water (ICW), extracellular water (ECW), and the derived parameter "dry weight". Results are available at the bedside within 2 minutes.


Locations(1)

Basildon University Hospital

Basildon, Essex, United Kingdom

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NCT07173426


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