Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%)

Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01673230

Acronym

ALTERVOL

Enrollment

Registered

2012-08-27

Start date

2012-09-30

Completion date

2015-12-31

Last updated

2019-12-27

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

Conditions

Ventricular Dysfunction

Brief summary

Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.

Interventions

PROCEDUREcardiac surgery for ventricular dysfunction

For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients \>18 years old in the immediate post-operative period after cardiac surgery * ASA 1 - 3 * Pre-operative LVEF≤45% * Sedated with Ramsay score: 6 * Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5 * With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2 * Affiliation to Health Insurance * Consent form signed

Exclusion criteria

* Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation * Intracardiac shunt * Weight less than 50 kg * History of central nervous system illness * Pulmonary oedema (clinical and/or radiological and/or wedge pressure\>18mmHg) * Right ventricular failure suspected (CVP\> wedge pressure) or diagnosed (trans thoracic and/or transesophageal echocardiography) * Acute kidney injury with oligoanuria * Severe post operative bleeding (chest tubes volume of \>200ml/h for 3 hours or more) * Severe hypoxia (PaO2/FIO2\< 100) * Administrative control (patient under guardianship or curatorship)

Design outcomes

Primary

Measure	Time frame	Description
Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)	2 hours	To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.

Secondary

Measure	Time frame	Description
Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.	2 hours	Secondary objectives : * Early optimization of hemodynamics after cardiac surgery, * To determine optimal threshold for ∆PP, ∆POP and PVI, * To compare dynamic (∆PP, ∆POP and PVI) with static (central venous pressure: CVP, wedge pressure) indices

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026