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NCT07868757Toborzás még nem indult

French Observatory on the Management of Cardiogenic Shock 2

French Observatory on the Management of Cardiogenic Shock 2 (FRENSHOCK 2)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 9.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The aim of this observational study is to describe the baseline characteristics, management strategies, and early outcomes (during hospitalisation and at 30 days) of patients admitted to intensive care with cardiogenic shock, regardless of aetiology. This prospective multicenter registry will enroll consecutive patients admitted to participating adult and pediatric critical care units in France, using current definitions and classifications of cardiogenic shock. The study aims to improve patient characterization and risk stratification and support the development of future interventional studies. 1,000 patients will be enrolled over 12 months, with follow-up at 30 days, 1 year, and through linkage with the French National Health Data System (SNDS) at 1 and 5 years.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Megfigyeléses
Résztvevők száma
1000 (tervezett)
Első benyújtás
2026. szept. 24.
Kezdés
2027. jan.
Elsődleges befejezés
2028. febr.
Fő szponzor
French Cardiology Society
NCT-szám
NCT07868757

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 1000
  • 2027. jan. és az elsődleges befejezés (2028. febr.) között
  • 2 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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A regiszterben nem jelölt feltételek

  • Adult Inclusion Criteria:
  • Patients covered by a national health insurance scheme.
  • Patients who have provided explicit consent for the use of their National Health Identifier (NIR) for research purposes. If obtaining consent is temporarily impossible due to the patient's clinical condition, the emergency consent procedure described in the protocol will be applied.
  • Patients meeting the FRENSHOCK definition of cardiogenic shock, with at least one positive criterion in each of the three categories below:
    • Low cardiac output, defined by at least one of the following:
    • Clinical: systolic blood pressure (SBP) < 90 mmHg and/or requirement for inotropic or vasopressor support to maintain SBP > 90 mmHg
    • Echocardiography: cardiac index (CI) < 2.2 L/min/m²
    • Hemodynamic assessment using a Swan-Ganz catheter or right heart catheterization: CI < 2.2 L/min/m²
    • Elevated pulmonary filling pressures/congestion and/or elevated right-sided filling pressures, defined by at least one of the following:
    • Clinical: left-sided and/or right-sided heart failure
    • Imaging: signs of congestion on chest X-ray or chest CT scan, or diffuse bilateral B-lines on lung ultrasound
    • Echocardiography: elevated left and/or right ventricular filling pressures according to current guideline recommendations
    • Right heart catheterization or Swan-Ganz catheterization: pulmonary capillary wedge pressure > 15 mmHg and/or right atrial pressure > 8 mmHg
    • End-organ hypoperfusion, defined by at least one of the following:
    • Clinical: new-onset oliguria < 0.5 mL/kg/h, mottling, altered mental status, or capillary refill time > 3 seconds
    • Laboratory findings: arterial lactate > 2 mmol/L and/or ScvO2/SvO2 < 60% and/or veno-arterial CO2 gap > 6 mmHg
    • Pediatric inclusion criteria :
    • Children must meet a revised and age-adapted FRENSHOCK definition of cardiogenic shock as described below, taking into account age- and/or weight-specific normal values (blood pressure, cardiac output, and urine output).
  • Parent(s) or legal guardian(s) having provided explicit consent for the use of the child's National Health Identifier (NIR) for research purposes. The child will receive information appropriate to their age and level of understanding.
  • Patients covered by a national health insurance scheme.
  • Patients with cardiogenic shock, defined as meeting at least one positive criterion in each of the following three categories:
    • Low cardiac output, defined by at least one of the following:
    • Clinical: systolic blood pressure below the 5th percentile for age and height and/or requirement for inotropic or vasopressor support
    • Echocardiography: cardiac index < 2.2 L/min/m² or left ventricular ejection fraction (LVEF) < 50%
    • Elevated pulmonary filling pressures/left-sided congestion and/or elevated right-sided filling pressures, defined by at least one of the following:
    • Clinical: left-sided and/or right-sided heart failure
    • Imaging: pulmonary congestion on chest radiography or chest CT scan, or diffuse bilateral B-lines on lung ultrasound
    • Echocardiography: elevated right- and/or left-sided filling pressures according to current guideline recommendations
    • End-organ hypoperfusion, defined by at least one of the following:
    • Clinical: new-onset oliguria, defined as urine output < 1 mL/kg/h in children younger than 2 years and < 0.5 mL/kg/h in children aged 2 years or older, mottling, altered mental status, or capillary refill time > 3 seconds
    • Laboratory findings: arterial lactate > 2 mmol/L and/or ScvO2/SvO2 < 60% and/or veno-arterial CO2 gap > 6 mmHg
    • Adult exclusion criteria :
  • Final diagnosis other than cardiogenic shock.
  • Unwitnessed and/or prolonged cardiac arrest (estimated low-flow duration > 30 minutes) and/or absence of return of spontaneous circulation at the time of hospital admission.
  • Post-cardiotomy cardiogenic shock.
  • Individuals deprived of liberty by judicial or administrative decision.
  • Adults under legal protection.
  • Refusal to participate or failure to implement the emergency inclusion procedure when required.
    • Pediatric exclusion criteria :
  • Preterm neonates (< 37 weeks corrected gestational age).
  • Neonates diagnosed with cardiogenic shock at birth, with the exception of fetal or neonatal arrhythmias.
  • Neonates with right-sided cardiogenic shock secondary to persistent pulmonary hypertension of the newborn.
  • Final diagnosis other than cardiogenic shock.
  • Unwitnessed and/or prolonged cardiac arrest (estimated low-flow duration > 30 minutes) and/or absence of return of spontaneous circulation at the time of hospital admission.
  • Cardiac arrest of non-cardiac origin.
  • Post-cardiotomy cardiogenic shock.
  • Patients not covered by a national health insurance scheme.
  • Refusal of participation by the parent(s) or legal guardian(s), or failure to implement the emergency inclusion procedure when required.

Életkor a regiszterben: 0 nap – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (2)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
CHU Nouvel Hôpital CivilStrasbourgFranciaországIsmeretlen állapot
Hopital RangueilToulouseFranciaországIsmeretlen állapot

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