Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients

Phase 1

Recruiting

• Conditions: sepsis, secondary or quaternary peritonitis; MedDRA version: 23.1Level: PTClassification code: 10040070Term: Septic shock Class: 100000004862; MedDRA version: 21.1Level: LLTClassification code: 10081559Term: Septic peritonitis Class: 10021881; MedDRA version: 20.0Level: PTClassification code: 10040047Term: Sepsis Class: 100000004862; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]

• Registration Number: CTIS2024-513526-27-00
• Lead Sponsor: niversitaetsklinikum Aachen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

the patient has a diagnosis of secondary or quaternary peritonitis., the time of source control is within 6 h of the indication (defined as the date and time of registration for surgery or minimally invasive procedure)., sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present., the SOFA score is = 8., the concentration of IL-6 is = 1000 pg/ml., antibiotic therapy is started within 12 h after admission to the intensive care unit., the informed consent form has been signed by the patient himself and/or his legal representative (such as his spouse, a proxy with effective power of attorney for health care or a court-appointed guardian) or by a consultant.

Exclusion Criteria

the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock., the patient is institutionalised by court or regulatory order., for female patients only: There is a pregnancy or the patient is breastfeeding., the patient is a minor (<18 years)., The patient has known chronic renal dysfunction requiring dialysis (creatinine = 3.4 mg/dl or creatinine clearance = 30 mL /min /1.73 m²)., the patient has acute, primarily non-infectious pancreatitis or mediastinitis., the BMI is > 40., the patient has a contraindication to the study medication., patient has participated in another drug study within the last 30 days., the patient has a dependent or employment relationship with the sponsor or investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified