Changes in PPV Induced by PLR Test to Predict Fluid Responsiveness in ICU

Completed

• Conditions: Acute Circulatory Failure

• Registration Number: NCT03225378
• Lead Sponsor: Centre Hospitalier Arras

Brief Summary

The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of blood that can be repeated as frequently as required without infusing a drop of fluid. Two recent meta-analyses of many studies have confirmed the reliability of the PLR test to predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the effects of the PLR must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the PLR hemodynamic effects with reliability. Moreover, cardiac output must be measured continuously and in real time.

In clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence.

Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (\<8 mL/kg of ideal body weight).

Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2017-09-21
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Mechanically ventilated patients

• Patients in whom the physician decides to perform a fluid challenge based on the presence of one of the following criteria:

  (1) systolic arterial pressure <90 mmHg, mean arterial pressure <65 mmHg, or the need for vasopressor infusion; (2) skin mottling; (3) urine output <0.5 mL/Kg/h for more than or equal to 2 hours; (4) lactate concentrations > 2 mmol/L

• Patients in whom the physician decides to perform a PLR test to predict fluid responsiveness

• Arterial catheter should be in place for invasive monitoring of arterial pressure and PPV

Non inclusion Criteria:

• Age <18 yrs
• Pregnancy
• Moribund patients
• Risk of fluid loading induced pulmonary edema
• Cardiac arrhythmias
• Contraindication to perform PLR (intracranial hypertension, pelvic fractures)

Exclusion Criteria :

• Changes in vasopressor and sedation agents dosages during the protocol
• Changes in ventilatory parameters during the protocol

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in cardiac output in all mechanically ventilated patients	Cardiac output will be measured immediately after the end of the volume expansion	The primary endpoint is the increase in cardiac output of more than or equal to 15% after 500 mL of volume expansion. All included patients are concerned by the primary outcome.

Secondary Outcome Measures

Name	Time	Method
Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory compliance	Cardiac output will be measured immediately after the end of the volume expansion	The secondary endpoint is the increase in cardiac output of more than or equal to 15% after 500 mL of volume expansion. Only patients with low tidal ventilation (\<8mL/kg of ideal body weight) and/or low respiratory compliance (\<30mL/cmH2O) are concerned by this secondary outcome.
Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activities	Cardiac output will be measured immediately after the end of the volume expansion	The secondary endpoint is the increase in cardiac output of more than or equal to 15% after 500 mL of volume expansion. Only patients with spontaneous breathing activities are concerned by this secondary outcome.

Trial Locations

Locations (12)

CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire; 🇫🇷 Amiens, France

CHU d'Amiens - Réanimation chirurgicale; 🇫🇷 Amiens, France

Centre Hospitalier d'Arras; 🇫🇷 Arras, France

Centre Hospitalier de Béthune; 🇫🇷 Bethune, France

CH Boulogne-sur-mer; 🇫🇷 Boulogne-sur-Mer, France

CHU de Caen; 🇫🇷 Caen, France

Centre Hospitalier de Cambrai; 🇫🇷 Cambrai, France

CHU de Dijon; 🇫🇷 Dijon, France

Centre Hospitalier de Lens - Anesthésie-Réanimation; 🇫🇷 Lens, France

Centre Hospitalier de Lens - Réanimation; 🇫🇷 Lens, France

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