Estimated Plasma Volume in Patients With Acute Heart Failure

NCT ID: NCT07085793

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-30

Brief Summary

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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

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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)

Conditions

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Acute Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

1

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semir Nouira, Pr

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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Emergency Department

Monastir, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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Estimated plasma volume- ePVS

Identifier Type: -

Identifier Source: org_study_id

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