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Recruiting NCT05586282

Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure

— Observational Cardiogenic Shock Postresuscitation Disease Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiogenic Shock, Postresuscitation Disease, Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

* 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.

Primary outcome measures

  • Fluid balance from Day 0 to day 3 [Time frame: Between Day 0 and Day 3]
Secondary outcome measures (12)
  • Fluid balance [Time frame: Day 1, Day 3, Day 7, Day 14]
  • Extra-vascular lung water index [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Serum albuminemia [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Serum lactatemia [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Arterial PaO2 [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Circulating cytokine inflammatory profile IL-33 [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Circulating cytokine inflammatory profile TNF-alpha [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Circulating cytokine inflammatory profile IL-6 [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Circulating cytokine inflammatory profile IL-1 [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • SOFA score [Time frame: Day 0, Day 1, Day 3, Day 7, Day 14]
  • Catecholamine-free days [Time frame: Day 0 to Day 7, Day 30]
  • Ventilatory-free days [Time frame: Day 0 to Day 7, Day 30]

Eligibility criteria

Inclusion criteria

  • 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.
  • Affiliation to social security (AME excluded)
  • 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

  • Onset of shock (catecholamine infusion) >12 hours prior to inclusion
  • Age <18 year old
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Européen Georges Pompidou — Paris

Identifiers

NCT: NCT05586282 · APH211381

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗