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RecruitingNCT05586282Updated Oct 15, 2024

Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure

An observational study in Cardiogenic Shock, Postresuscitation Disease and Septic Shock, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Cardiogenic Shock
  • Postresuscitation Disease
  • Septic Shock
03

In context

Post-Cardiac Arrest Syndrome

26 studies on the registry are indexed under Post-Cardiac Arrest Syndrome; 9 are open to participants now.

Browse Post-Cardiac Arrest Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  1. Onset of shock (catecholamine infusion) >12 hours prior to inclusion
  2. Age \<18 year old
  3. Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
380 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with a circulatory failure

    All patients hospitalized in ICU with a circulatory failure due to septic shock, cardiogenic shock, or post-resuscitation syndrome.

06

What researchers measure

Primary outcomes

  1. Fluid balance from Day 0 to day 3

    (ml/kg of initial body weight). The fluid balance, routinely monitored in ICU, represents fluid intakes (perfusion, oral intakes,..) - fluid losses (diuresis, diarrhea,...)

    Time frame: Between Day 0 and Day 3

Secondary outcomes

  1. Fluid balance

    (ml/kg of initial body weight). The fluid balance, routinely monitored in ICU, represents fluid intakes (perfusion, oral intakes,..) - fluid losses (diuresis, diarrhea,...)

    Time frame: Day 1, Day 3, Day 7, Day 14

  2. Extra-vascular lung water index

    Extra-vascular lung water index (EVLWi, ml/kg) and pulmonary vascular permeability index measured by transpulmonary thermodilution at corresponding time-points

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  3. Serum albuminemia

    g/L

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  4. Serum lactatemia

    mmoles/L

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  5. Arterial PaO2

    (mmHg)

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  6. Circulating cytokine inflammatory profile IL-33

    (pg/ml)

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  7. Circulating cytokine inflammatory profile TNF-alpha

    (pg/ml)

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  8. Circulating cytokine inflammatory profile IL-6

    (pg/ml)

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  9. Circulating cytokine inflammatory profile IL-1

    (pg/ml)

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  10. SOFA score

    Association between circulating candidate proteins, the immune-inflammatory profile of the patients and SOFA score

    Time frame: Day 0, Day 1, Day 3, Day 7, Day 14

  11. Catecholamine-free days

    Number of days alive without receiving any catecholamine

    Time frame: Day 0 to Day 7, Day 30

  12. Ventilatory-free days

    Number of days alive without receiving any machenical ventilation, invasive or non-invasive

    Time frame: Day 0 to Day 7, Day 30

  13. Renal replacement therapy-free

    Number of days alive without receiving any renal replacement therapy

    Time frame: Day 0 to Day 7, Day 30

  14. Mortality

    Time frame: Day 30

07

Study locations

1 of 1 sites recruiting
  • Hôpital Européen Georges Pompidou
    Paris, 75015, France
    • Nicolas BRECHOT, MD, PhD · Contact · nicolas.brechot@aphp.fr · +33 1 56 09 23 42
    • Nicolas BRECHOT, MD, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05586282
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Oct 19, 2022
Start date
Mar 20, 2023
Primary completion
Mar 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Oct 15, 2024

Study contacts

Nicolas BRECHOT, MD, PhD
Contact
nicolas.brechot@aphp.fr
+331 56 09 23 42

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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