Applicability of Fluid Responsiveness Indices in Circulatory Failure (AFRIC Study) Study Project (AFRIC)

Applicability of Fluid Responsiveness Indices in Patients With Acute Circulatory Failure (AFRIC Study)

Fluid administration is one of the main strategies for patients with acute circulatory failure. However, about half of the patients could not benefit from the fluid administration after the ICU admission. Thus predict the effect of fluid responsiveness is essential. There are sevral indices or tests can be used, such as pulse pressure variation (PPV), end-expiratory occulsion test (EEOT), passive leg raising (PLR), etc. Question of the prevalence of cases in which the different predictive indices of fluid responsiveness in intensive care unit (ICU) are not applicable.

Study Overview

• Status: Recruiting
• Conditions: Shock; Acute Circulatory Failure
• Intervention / Treatment: Other: Passive leg raising

Detailed Description

Fluid administration is one of the first-line therapies for most patients with acute circulatory failure. And it was supposed to increase cardiac preload and thus output significantly. However, it only has this effect if cardiac output is dependent on cardiac preload, that is if both ventricles work on the ascending part of the Frank-Starling curve. Our group had already shown that, in half of the critically ill patients admitted in ICU, fluid administration is likely to exert only deleterious effects without any hemodynamic benefit. To predict whether it will exert beneficial effects or not before administering the fluid therapy, a "dynamic approach" has been developed. It consists of observing the effects of changes of preload induced by various tests on cardiac output. 1) Pulse pressure variation: mechanical ventilation induces cyclical changes in cyclical changes in cardiac preload and right ventricular afterload due to cardiopulmonary interactions. If both ventricles are in a preload-dependent state, these variations will induce a cyclical variation in stroke volume. The latter being physiologically related to the pulsed arterial pressure (systolic - diastolic), the respiratory variation of the pulsed arterial pressure (PPV) indicates the existence of a preload-dependence of the two ventricles. 2) The End-expiratory occlusion test (EEOT): this is another method that takes advantage of heart-lung interactions to predict fluid responsiveness in ventilated patients. During mechanical ventilation, each insufflation increases intrathoracic pressure, which hinders systemic venous return. Thus, interrupting the respiratory cycle at the end of expiration inhibits this cyclic hindrance to venous return, increases cardiac preload and cardiac output if both ventricles are preload dependent. The duration of the EEOT must be at least 15 seconds. 3): Passive leg raising (PLR): when a patient is in a recumbent position, the elevation of the lower extremities and the horizontalization of the trunk passively transfers a significant volume of blood from the lower part of the body to the heart chambers and mimics volume expansion.

Numerous studies have reported that the increased cardiac output induced by PLR predicts fluid responsiveness. There is always the question of the prevalence of cases in which the different predictive indices of fluid responsiveness are not applicable and data on this issue are scarce, incomplete, and unsatisfactory.

Few studies have systematically investigated the number of patients in whom PPV cannot be used in the ICU settings. Some studies have reported a very low prevalence of cases where PPV was usable but they included the entire ICU population on a given day, including many patients who did not have an acute circulatory failure, which had no sense since PPV is only used in patients in whom the question of fluid therapy arises. Other studies have reported a higher prevalence of cases where PPV is usable, but they have only looked at the first 24 hours of hospitalization or have focused on patients with an unstable hemodynamic event. Finally, no study has ever studied the prevalence of cases where the respiratory variation of the PLR, or the EEOT are not applicable.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France
    • Recruiting
    • Medical Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with acute circulatory failure need to evaluate fluid responsiveness.

Description

Inclusion Criteria:

1. Age ≥ 18

2. The presence of acute circulatory insufficiency defined by the following pragmatic criteria:

   • Prior administration of at least 1000 mL of crystalloid or colloid solute during a volemic expansion in the previous 12 hours
   • Norepinephrine administration/lactate ≥ 1.5 mmol/L

Exclusion Criteria:

• No strict exclusion criterion only if the refusal of the patient.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of cases and reasons in which the conditions that the PPV cannot be correctly interpreted.	By using one arterial line, the scope at the bedside could have a PPV value that automatly calculated on the screen.	One minute at the bedside
The prevalence of cases and reasons in which the conditions that the EEOT cannot be correctly interpreted.		15 seconds for EEOT
The prevalence of cases and reasons in which the conditions that the PLR cannot be correctly interpreted.		One minute fot the passive leg raising

Collaborators and Investigators

• Sponsor: Bicetre Hospital

Publications and helpful links

General Publications

• Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
• Heenen S, De Backer D, Vincent JL. How can the response to volume expansion in patients with spontaneous respiratory movements be predicted? Crit Care. 2006;10(4):R102. doi: 10.1186/cc4970.
• Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
• Benes J, Kirov M, Kuzkov V, Lainscak M, Molnar Z, Voga G, Monnet X. Fluid Therapy: Double-Edged Sword during Critical Care? Biomed Res Int. 2015;2015:729075. doi: 10.1155/2015/729075. Epub 2015 Dec 22.
• Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8. doi: 10.1164/ajrccm.162.1.9903035.
• Soubrier S, Saulnier F, Hubert H, Delour P, Lenci H, Onimus T, Nseir S, Durocher A. Can dynamic indicators help the prediction of fluid responsiveness in spontaneously breathing critically ill patients? Intensive Care Med. 2007 Jul;33(7):1117-1124. doi: 10.1007/s00134-007-0644-9. Epub 2007 May 17.
• Muller L, Louart G, Bousquet PJ, Candela D, Zoric L, de La Coussaye JE, Jaber S, Lefrant JY. The influence of the airway driving pressure on pulsed pressure variation as a predictor of fluid responsiveness. Intensive Care Med. 2010 Mar;36(3):496-503. doi: 10.1007/s00134-009-1686-y. Epub 2009 Oct 22.
• Malbrain ML, Reuter DA. Assessing fluid responsiveness with the passive leg raising maneuver in patients with increased intra-abdominal pressure: be aware that not all blood returns! Crit Care Med. 2010 Sep;38(9):1912-5. doi: 10.1097/CCM.0b013e3181f1b6a2. No abstract available.
• Delannoy B, Wallet F, Maucort-Boulch D, Page M, Kaaki M, Schoeffler M, Alexander B, Desebbe O. Applicability of Pulse Pressure Variation during Unstable Hemodynamic Events in the Intensive Care Unit: A Five-Day Prospective Multicenter Study. Crit Care Res Pract. 2016;2016:7162190. doi: 10.1155/2016/7162190. Epub 2016 Mar 31.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (ACTUAL): September 16, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pulse pressure variation; passive leg raising; end-expiratory occulsion test
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 2017-A03580-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No