Estimated Plasma Volume in Patients With Acute Heart Failure

Prognostic Value of Estimated Plasma Volume in Patients With Acute Heart Failure

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07085793

Acronym

ePVS

Enrollment

2500

Registered

2025-07-25

Start date

2019-01-01

Completion date

2023-12-30

Last updated

2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

Keywords

Estimated plasma volume status (ePVS)

Brief summary

Congestion plays an essential role in acute heart failure (AHF) outcomes. Estimated plasma volume status (ePVS), derived from simple hematological parameters, may offer prognostic value. The objectif is to assess the prognostic value of admission ePVS, calculated using Duarte and Hakim formulas, for short- and long-term mortality and/or readmission in patients hospitalized for AHF.

Detailed description

it is a prospective cross-sectional study in the emergency department of Fattouma Bourguiba University Hospital of Monastir, Tunisia.This study was approved by the Institutional Review Boardof our institute and conducted according to the revised Declaration of Helsinki. The requirement of written informed consent was waived, as this study is observational. an opt-out method was used for participant recruitment. ePVS at admission was calculated as follows: * Duarte ePVS= 100-ht(%) /Hb(g/dl). * Hakim ePVS = \[(actual plasma volume-ideal plasma volume)/ideal plasma volume\] × 100 Actual plasma volume: (1-hematocrit) × (a+b×body weight in kg). Ideal plasma volume = c×body weight in kg. (males: a = 1530, b = 41.0, c = 39; females; a = 864, b = 47.9, c = 40)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Inclusiuon criteria : * Patients aged over 18 * diagnosis of AHF based on clinical examination, echocardiography, the value of BNP or NT pro-BNP and expert opinion. *

Exclusion criteria

: * pregnancy * end-stage or severe renal failure with creatinine clearance \< 15 ml/min * hemodialysis. * refusal to consent * Pregnant or breast feeding women. * Alteration of consciousness GCS \< 15 * Critically ill patients needing immediate mechanical hemodynamic of ventilatory support. * Inability to follow instructions or comply with follow-up procedures.

Design outcomes

Primary

Measure	Time frame	Description
readmission for AHF and/or all-cause mortality	30 days	readmission for AHF and/or all-cause mortality at 1 month

Countries

Tunisia

Outcome results