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Estimated Plasma Volume in Patients With Acute Heart Failure (ePVS)

U

University of Monastir

Status

Completed

Conditions

Acute Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT07085793
Estimated plasma volume- ePVS

Details and patient eligibility

About

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.

Full description

We conducted a prospective cross-sectional study in the emergency department of Fattouma Bourguiba University Hospital of Monastir, Tunisia, from January,1st 2019 to December,30th 2020.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. We used an opt-out method 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)

Enrollment

2,500 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

2,500 participants in 1 patient group

1
Description:
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Trial contacts and locations

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Data sourced from clinicaltrials.gov

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