Clinical trial NCT05586282: Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure
Official title: Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Postresuscitation Disease
Septic Shock
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 380
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: All patients hospitalized in ICU with a circulatory failure due to septic shock, cardiogenic shock, or post-resuscitation syndrome.

Brief summary: * Testing the association between circulating candidate proteins and the level of vascular leakage for three distinct forms of circulatory failure: cardiogenic shock, septic shock, and post-resuscitation syndrome.
* Describing immuno-inflammatory profiles associated with massive vascular leakage during those three forms of circulatory failure in humans

Detailed description: Circulatory shocks are responsible for one third of intensive care unit (ICU) admissions (20,000 patients per year in France) and are associated with 40% mortality \[1,2\]. Vascular hyperpermeability (also called vascular leakage) is a major feature of circulatory failure. During systemic inflammatory response syndrome (SIRS), massive vascular leakage affects macro and micro-circulation, and participates in the development of multiple organ failure \[1,3\]. Accordingly, fluid balance (the difference between fluid input and output) correlates independently with mortality during both septic and cardiogenic shock \[4-7\] and controlling capillary leakage was highly beneficial in numerous animal models of circulatory failure \[8-10\]. However, the determinants of vascular leakage remain poorly understood in humans.

The purpose of this study is to evaluate the link between circulatory levels of several proteins and the level of vascular leakage, in three distinct types of circulatory shocks.

Eligibility criteria: Inclusion Criteria:

1. Informed consent from patient or a legal representative/family member/close relative. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
2. Affiliation to social security (AME excluded)
3. Patient with one of the circulatory failures described below:

   * septic shock
   * cardiogenic shock
   * post-resuscitation syndrome
   * Cardiogenic shock:

     * Need for a catecholamine support to maintain mean arterial pressure\>65 mmHg, AND
     * Cardiac index \<2 L/min/m2 or left ventricular ejection fraction (LVEF)\<35%, AND
     * Lactate \>2.0 mmol/l
   * Post-resuscitation syndrome:

     * Cardiac arrest (absence of spontaneous respiration, palpable heartbeat, and responsiveness to stimuli\> 1 min) with a compatible electrocardiogram (asystole/pulseless electrical activity/ventricular tachycardia), AND
     * Need for a catecholamine support to maintain mean arterial pressure\>65 mmHg, AND
     * Lactate \>2.0 mmol/l
   * Septic shock:

     * Suspected or proven bacterial infection
     * Need for a vasopressor support to maintain mean arterial pressure\>65 mmHg
     * Lactate \>2.0 mmol/l
     * Cardiac index\>3L/min/m2 or LVEF\>40%

Exclusion Criteria:

1. Onset of shock (catecholamine infusion) \>12 hours prior to inclusion
2. Age \<18 year old
3. Pregnancy

Primary outcomes:
measure: Fluid balance from Day 0 to day 3
timeFrame: Between Day 0 and Day 3
Secondary outcomes:
measure: Fluid balance
timeFrame: Day 1, Day 3, Day 7, Day 14
measure: Extra-vascular lung water index
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Serum albuminemia
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Serum lactatemia
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Arterial PaO2
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Circulating cytokine inflammatory profile IL-33
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Circulating cytokine inflammatory profile TNF-alpha
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Circulating cytokine inflammatory profile IL-6
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Circulating cytokine inflammatory profile IL-1
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: SOFA score
timeFrame: Day 0, Day 1, Day 3, Day 7, Day 14
measure: Catecholamine-free days
timeFrame: Day 0 to Day 7, Day 30
measure: Ventilatory-free days
timeFrame: Day 0 to Day 7, Day 30
measure: Renal replacement therapy-free
timeFrame: Day 0 to Day 7, Day 30
measure: Mortality
timeFrame: Day 30
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
References: