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

Radboud University Nijmegen Medical Centre0 个研究点目标入组 20 人开始时间: 2012年7月19日最近更新: 2020年11月30日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•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

发起方

Radboud University Nijmegen Medical Centre