The effects of interferon-gamma on sepsis-induced immunoparalysis, a randomised double-blind placebo-controlled pilot (Phase IIIb) study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Written informed consent from patient of legal representative
2. Age >18 years
3. Presence of septic shock of bacterial origin (A-C required):
A. Evidence of bacterial infection (last 96 hours), at least one: pathogenic microorganism in blood, sputum, urine, normally sterile body fluid, or on central venous catheter; Focus of infection identified (e.g. ruptured bowel, purulent drainage/sputum); or leukocytes in normally sterile body fluid
B. Two SIRS criteria (last 24 hours): fever (>38.3 *C), hypothermia (<35.6 *C), tachycardia (>90bpm), tachypnea (>20/min), or PaCO2 <32 mmHg, or mechanical ventilation, leukocytosis (>12,000/µl), leucopenia (<4,0000/µl), or >10% immature forms.
C. Presence of shock with need for vasopressor therapy to maintain SBP >= 90 mmHg.

Exclusion Criteria

1. Pregnancy or lactating
2. Subjects with a history of allergy or intolerance to IFN-*
3. Systemic autoimmune disease, hematologic disease (neoplasma, acute leukemia), transplant patients, or patients on steroid medication receiving a prednisolon equivalent of > 5 mg per day
4. Human immunodeficiency virus positivity
5. Presence of an advanced directive to withhold or to withdraw life sustaining treatment
6. Underlying disease with a prognosis for survival < 3 months, or moribund patient highly likely to die within 24 hours.
7. Cardiopulmonary resuscitation (<72 hours) before enrolment
8. Acute myocardial infarction or pulmonary embolisation (<72 hours)
9. Participation in a clinical trial until 30 days prior to inclusion
10. Subjects with a history of documented epileptic seizures
11. Subjects with severe renal impairment (creatinine clearance less than 30 mL/min)
12. Subjects with severe liver failure (impaired synthesis of proteins such as coagulation factors manifested by increased prothrombine time)
13. Subjects with an absolute neutrophil count of less than 500/mm3 at study entry

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the (preliminary) efficacy of IFN-γ as adjunctive treatment in<br /><br>combination with standard therapy for the treatment of patients presenting with<br /><br>septic shock, by assessment of a series of surogate immunological parameters.<br /><br>The primary endpoint is the TNF-a secretion by ex vivo LPS-stimulated<br /><br>leukocytes as a marker of immunosuficiency/antimicrobial response. </p><br>

Secondary Outcome Measures