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

NCT03225378 | Completed

• 1 other identifier: 2017_01
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 12

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.

Conditions

Acute Circulatory Failure

Keywords

Fluid responsiveness; Passive leg raising; Pulse pressure variation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

Acute circulatory failure

Mechanically ventilated patients displaying acute circulatory failure in whom the physician decides to perform a fluid challenge (fluid loading of 500 mL of crystalloid solution) and a passive leg raising test to predict fluid responsiveness.

Other: Fluid loading of 500 mL of crystalloid solution; Other: Passive Leg Raising test

Interventions

Fluid loading of 500 mL of crystalloid solution OTHER

Infusion of 500 mL of crystalloid solution in less than 15 minutes

Acute circulatory failure

Passive Leg Raising test OTHER

This intervention is done before the fluid loading in order to predict fluid responsiveness.

Acute circulatory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Arras: lead

Study Sites (12)

CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire

Amiens, France

Location

CHU d'Amiens - Réanimation chirurgicale

Amiens, France

Location

Centre Hospitalier d'Arras

Arras, France

Location

Centre Hospitalier de Béthune

Béthune, France

Location

CH Boulogne-sur-mer

Boulogne-sur-Mer, France

Location

CHU de Caen

Caen, France

Location

Centre Hospitalier de Cambrai

Cambrai, France

Location

CHU de Dijon

Dijon, France

Location

Centre Hospitalier de Lens - Anesthésie-Réanimation

Lens, France

Location

Centre Hospitalier de Lens - Réanimation

Lens, France

Location

CHRU de Lille - Réanimation Médicale

Lille, France

Location

CHU de Rouen

Rouen, France

Location

Related Publications (6)

• 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.

  PMID: 26825952 RESULT

• 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.

  PMID: 26741579 RESULT

• 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.

  PMID: 26152341 RESULT

• Mallat J, Abou-Arab O, Lemyze M, Saleh D, Guinot PG, Fischer MO. Changes in central venous-to-arterial PCO2 difference and central venous oxygen saturation as markers to define fluid responsiveness in critically ill patients: a pot-hoc analysis of a multi-center prospective study. Crit Care. 2024 Nov 8;28(1):360. doi: 10.1186/s13054-024-05156-y.

  PMID: 39516883 DERIVED

• Mallat J, Lemyze M, Fischer MO. Passive leg raising test induced changes in plethysmographic variability index to assess fluid responsiveness in critically ill mechanically ventilated patients with acute circulatory failure. J Crit Care. 2024 Feb;79:154449. doi: 10.1016/j.jcrc.2023.154449. Epub 2023 Oct 17.

  PMID: 37857068 DERIVED

• 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.

  PMID: 35842352 DERIVED

MeSH Terms

Conditions

Shock

Interventions

Crystalloid Solutions

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jihad MALLAT, MD

  Centre Hospitalier Arras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: September 21, 2017
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)