Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis

Launched by RWTH AACHEN UNIVERSITY · Nov 2, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Pentaglobin® (IgGAM) on patients with peritonitis, a serious infection in the abdominal cavity. The goal is to see if this treatment can help improve patient outcomes, such as survival rates and overall health scores after surgery to control the infection. Researchers also want to identify specific markers in patients' blood that may help determine who will benefit the most from this treatment. If successful, this could lead to more personalized care for patients with this condition.

To be eligible for the trial, participants must be diagnosed with a specific type of peritonitis and have had surgery to address the infection within six hours of diagnosis. They should also be experiencing severe illness (sepsis) and meet certain health criteria. Participants can expect close monitoring and support throughout the study, and their involvement will help gather important information that could lead to better treatments for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient is diagnosed with secondary or quaternary peritonitis
• • 2. The time of the surgical infectious source control is within 6 hours of indication (defined as date and time of registration for surgical or minimal invasive procedure).
• • 3. Sepsis and / or septic shock (according to the current sepsis guideline of the German Sepsis Society).
• • 4. SOFA Score ≥ 8
• • 5. The concentration of IL-6 is ≥ 1000 pg / ml
• • 6. Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit
• • 7. The informed consent form has been signed by the patient and / or by his legal representative (such as his spouse, an health care proxy authorized or a legal representative) or by a consultant physician
• • Exclusion criteria
• • 1. Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock.
• • 2. For female patients : The patient is pregnant or breastfeeding
• • 3. The patient is a minor (\< 18 years of age).
• • 4. The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL / min / 1.73 m2).
• • 5. The patient has acute, primarily non-infectious pancreatitis or mediastinitis
• • 6. The patient has a BMI\> 40.
• • 7. The patient has any contraindication to study drug.
• • 8. The patient has participated in another clinical trial within the last 30 days.
• • 9. The patient is in a dependent or employment relationship with the sponsor or investigator.
• • 10. The patient is institutionalized by court or government order