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

Acute Circulatory Failure Clinical Trial

— VPP-ImPRoVE  

Official title:

Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225378
• Other study ID #: 2017_01
• Status: Completed
• Start date: September 21, 2017
• Est. completion date: September 20, 2021

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Arras
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Circulatory Failure
• Shock

Intervention

Other:
• Fluid loading of 500 mL of crystalloid solution
Infusion of 500 mL of crystalloid solution in less than 15 minutes
• Passive Leg Raising test
This intervention is done before the fluid loading in order to predict fluid responsiveness.

Locations

Country	Name	City	State
France	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	CHRU de Lille - Réanimation Médicale	Lille
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Arras

Country where clinical trial is conducted

France, 

References & Publications (3)

Cherpanath TG, Hirsch A, Geerts BF, Lagrand WK, Leeflang MM, Schultz MJ, Groeneveld AB. Predicting Fluid Responsiveness by Passive Leg Raising: A Systematic Review and Meta-Analysis of 23 Clinical Trials. Crit Care Med. 2016 May;44(5):981-91. doi: 10.1097 — View Citation

Mallat J, Meddour M, Durville E, Lemyze M, Pepy F, Temime J, Vangrunderbeeck N, Tronchon L, Thevenin D, Tavernier B. Decrease in pulse pressure and stroke volume variations after mini-fluid challenge accurately predicts fluid responsiveness†. Br J Anaesth — View Citation

Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in cardiac output in all mechanically ventilated patients	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.	Cardiac output will be measured immediately after the end of the volume expansion
Secondary	Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activities	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.	Cardiac output will be measured immediately after the end of the volume expansion
Secondary	Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory compliance	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.	Cardiac output will be measured immediately after the end of the volume expansion