Clinical trial NCT03225378: Changes in PPV Induced by PLR Test to Predict Fluid Responsiveness in ICU
Official title: Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Circulatory Failure
Keywords: Fluid responsiveness
Passive leg raising
Pulse pressure variation
Lead sponsor: Centre Hospitalier Arras
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients displaying acute circulatory failure signs in whom the physician decides to perform a fluid challenge and a PLR test to predict fluid responsiveness.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Increase in cardiac output in all mechanically ventilated patients
timeFrame: Cardiac output will be measured immediately after the end of the volume expansion
Secondary outcomes:
measure: Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activities
timeFrame: Cardiac output will be measured immediately after the end of the volume expansion
measure: Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory compliance
timeFrame: Cardiac output will be measured immediately after the end of the volume expansion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire
city: Amiens
country: France
facility: CHU d'Amiens - Réanimation chirurgicale
city: Arras
country: France
facility: Centre Hospitalier d'Arras
city: Bethune
country: France
facility: Centre Hospitalier de Béthune
city: Boulogne-sur-Mer
country: France
facility: CH Boulogne-sur-mer
city: Caen
country: France
facility: CHU de Caen
city: Cambrai
country: France
facility: Centre Hospitalier de Cambrai
city: Dijon
country: France
facility: CHU de Dijon
city: Lens
country: France
facility: Centre Hospitalier de Lens - Anesthésie-Réanimation
city: Lens
country: France
facility: Centre Hospitalier de Lens - Réanimation
city: Lille
country: France
facility: CHRU de Lille - Réanimation Médicale
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: Centre Hospitalier Arras
name: Jihad MALLAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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/CCM.0000000000001556.
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 responsivenessdagger. Br J Anaesth. 2015 Sep;115(3):449-56. doi: 10.1093/bja/aev222. Epub 2015 Jul 6.
citation: Mallat J, Fischer MO, Granier M, Vinsonneau C, Jonard M, Mahjoub Y, Baghdadi FA, Preau S, Poher F, Rebet O, Bouhemad B, Lemyze M, Marzouk M, Besnier E, Hamed F, Rahman N, Abou-Arab O, Guinot PG. Passive leg raising-induced changes in pulse pressure variation to assess fluid responsiveness in mechanically ventilated patients: a multicentre prospective observational study. Br J Anaesth. 2022 Sep;129(3):308-316. doi: 10.1016/j.bja.2022.04.031. Epub 2022 Jul 14.