NCT02647554已完成4 期
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China
详细描述
Investigational drug：Ulinastain for Injection
Study title： A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China
Principal Investigator：Professor Bin Du, Medical Intensive Care Unit, Peking Union Medical College Hospital; Professor Xiangyou Yu, Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
Study subjects： Adult patients with sepsis and septic shock will be eligible for inclusion if all of the inclusion criteria are met within 48 hours of meeting criteria of sepsis-3 definition
Study phase： Investigator Initiated Trial(IIT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for inclusion if all of the inclusion criteria are met
- •Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine(ESICM)
- •Suspected or confirmed infection AND
- •Evidence of acute organ dysfunction • in patients not known to have preexisting organ dysfunction (The baseline SOFA score can be assumed to be zero): total SOFA score ≥2 points from 48 hours before infection to 24 hours after infection.
- •in patients known to have preexisting organ dysfunction (The baseline SOFA score can be assumed according to baseline conditions): changes of total SOFA score ≥2 points from 48 hours before infection to 24 hours after infection.
- •2）48 hours within diagnosis of sepsis 3）Signed and dated informed consent should be obtained prior to any screening procedures from subjects (or legal representatives). If the subject is unable to provide consent, it could be obtained from legal representatives according to local regulation. Consent from subject should be obtained afterwards when available.
- •4） Fertile men or women should agree to use efficient birth control methods during the treatment period and at least 28 days after last dose. Fertile is defined as biologically fertile and sexually active from investigator's view.
- •5） Non-childbearing women (meet at least one of following criteria):
- •Past hysterectomy or bilateral oothectomy；
- •Medically confirmed ovarian failure, or menopause (amenorrhea for 12 month or more and with no other pathological or physiological reason)
排除标准
- •Age < 18 years, or age>80 years 2) Pregnancy or lactating 3) New York Heart Association Class IV congestive heart failure, nonseptic cardiogenic shock, or uncontrolled acute blood loss 4) Severe, preexisting, parenchymal liver disease with clinically significant portal hypertension, Child-Pugh C stage cirrhosis or acute liver failure 5) Receipt of a solid-organ or bone marrow transplant 6) Advanced pulmonary fibrosis or non invasive ventilation before study entry 7) Myocardial infarction within the previous 3 months 8) Cardiopulmonary resuscitation within 72 hours before study entry 9） Invasive fungal infection or active pulmonary tuberculosis 10) Full-thickness thermal or chemical burn involving 30% or more of body surface area 11) Evidence of significant drug- or disease-induced immunosuppression
- •· Evidence of moderate or severe neutropenia, i.e. absolute neutrophil count (ANC) < 1.0 x 10^9/L
- •Administration of high doses of corticosteroids, i.e. doses of > 20 mg/day of prednisone or equivalent, for ≥ 2 weeks immediately prior to evaluation for enrollment. Hydrocortisone at dose ≤ 300 mg/d for treatment of septic shock is acceptable.
- •Immunomodulatory medication (e.g. cyclosporine, azathioprine, OKT3), chemotherapy, or radiation therapy within 2 months before study entry
- •Known HIV seropositivity
- •Any disease sufficiently advanced to suppress resistance to infection
- •Non-remission stage of hematological/lymphoid tumor 12) Previous Xuebijing, thymosin or IVIG Within 2 months before study entry 12) Inability to obtain informed consent or assent 13) Participation in an investigational clinical trial within 6 months of screening 14) Expected survival < 2 months or chronic vegetative state 15) Lack of commitment to full, aggressive, life support 16) History of hypersensitivity to ulinastatin or any excipients or preservatives
研究组 & 干预措施
Ulinastatin group
Experimental
Ulinastain treatment group：400,000 IU ulinastatin will be reconstituted in 10 mL of 0.9% normal saline, and then dissolved in 100 mL of 0.9% normal saline every 8 hours for 10 days in a double-blind fashion.
干预措施: ulinastatin (Drug)
Placebo group
Placebo Comparator
Placebo control group：Matching with medication
干预措施: Placebo (Drug)
结局指标
主要结局
all cause mortality
时间窗: 28 days
death from all causes at 28-days
次要结局
- mortality(90 days)
- mortality rate at hospital discharge(through hospital discharge, an average of 21 days)
- serum TNF-α(Day 1,3,6,10 after randomization)
- ICU-free days(28 days)
- SOFA score(Day 1,3,6,10,14,28 after randomization)
- incidence of supportive care(through ICU discharge, an average of 14 days)
- serum IL-6(Day 1,3,6,10 after randomization)
- mortality in ICU(through ICU discharge, an average of 14 days)
- serum hsCRP(Day 1,3,6,10 after randomization)
- renal function(Day 1-10, 14, 28 after randomization)
- serious adverse events(till 28 days after randomization)
- duration of supportive care(through ICU discharge, an average of 14 days)
- blood lactate concentration(Day 1,3,6,10 after randomization)
- serum IL-10(Day 1,3,6,10 after randomization)
- complete blood counts(Day 1-10, 14, 28 after randomization)
- liver function (alanine aminotransferase, ALT)(Day 1-10, 14, 28 after randomization)
- Activities of daily living (ADL) at hospital discharge(through hospital discharge, an average of 21 days)
- fluid balance(through ICU discharge, an average of 10 days)
- liver function (bilirubin)(Day 1-10, 14, 28 after randomization)
- adverse events(till 28 days after randomization)
- liver function (Aspartate transaminase, AST)(Day 1-10, 14, 28 after randomization)
- respiratory function(Day 1-10, 14, 28 after randomization)
研究者
Bin Du
Director of Medical ICU
Peking Union Medical College Hospital
研究点 (1)
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