Clinical trial NCT05046340: Applicability of Fluid Responsiveness Indices in Circulatory Failure (AFRIC Study) Study Project
Official title: Applicability of Fluid Responsiveness Indices in Patients With Acute Circulatory Failure (AFRIC Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Acute Circulatory Failure
Keywords: pulse pressure variation
passive leg raising
end-expiratory occulsion test
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with acute circulatory failure need to evaluate fluid responsiveness.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The prevalence of cases and reasons in which the conditions that the PPV cannot be correctly interpreted.
timeFrame: One minute at the bedside
measure: The prevalence of cases and reasons in which the conditions that the EEOT cannot be correctly interpreted.
timeFrame: 15 seconds for EEOT
measure: The prevalence of cases and reasons in which the conditions that the PLR cannot be correctly interpreted.
timeFrame: One minute fot the passive leg raising
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Medical Intensive Care Unit
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.