A Phase 1b/2a Trial to Evaluate Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care.

Korábbi kezelés

• Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
• Patients receiving Ang II and/or levosimendan
• Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).
• Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial.
• Sustained SBP > 120 mmHg during the hour prior to randomization.
• Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed.
• Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization.

Más betegség

• Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.
• Stroke or transient ischemic attack within the last 3 months.
• Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.
• Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.
• Patients with valvular heart diseases as the primary cause of cardiogenic shock.
• Other known causes of shock, namely
  • Hypovolemia
  • Hemorrhage
  • Anaphylaxis
  • Intoxication (e.g., drug-induced shock)
  • Dynamic left ventricular outflow tract obstruction
  • isolated right heart failure, including cardiac tamponade and/or pulmonary embolism
  • Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture
  • Inappropriate pacing or shock resulting from ICD malfunction

Laborértékek

• Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score >30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary failure and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR <20 ml/min/1.73 m2 or chronic dialysis.
• Patients who have severe immune suppression: recent (<3 months) chemotherapy and/or severe neutropenia (neutrophile count <500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (<3 months) organ transplantation.

Életkor

• Patients below the age of 18 or above 80 years.

Egyéb

• Patients being longer than 24 hours in the ICU at the time of randomization.
• SCAI Shock Stage E.
• Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US).
• CPR lasting more than 15 minutes and/or the patient is not conscious at randomization.
• Pericardial constriction.
• Patients with untreated sepsis.
• Women who are pregnant or breastfeeding.
• Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only).

• Signed informed consent.
• Diagnosis of CS based on the following entry criteria:
  • Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg
  • Lactate ≥ 2.0 mmol/L
  • High DPP3 concentration ≥ 30 ng/mL
• Etiology of CS must be one of the following: ACS, septic (according to SEPSIS 3 criteria) or adHF origin