CTRI/2016/06/007046尚未招募4 期
Prospective, Multi-centric, Double-blind, Comparative, Clinical Study To Compare The Efficacy And Safety of Intravenous Ulinastatin versus Placebo Adjunct To Standard Supportive Care In Subjects With Severe Sepsis, A Phase IV study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Percentage of subjects with reduction in mortality rate
研究概览
简要总结
Studies in patients with sepsis have shown thatthere is a decrease in serum levels of Ulinastatin, with lowest levels beingfound in patients with severe sepsis and septic shock. Previousstudies have shown that Ulinastatin administration to patients with SIRSreduces the levels of pro-inflammatory cytokines such as polymorphonuclearleukocyte elastase, tumor necrosis factor-alpha and Interleukin 6 andserum C‑reactive protein and increase in the levels of anti‑inflammatorycytokine Interleukin-10. In few studies, Ulinastatin has also shown reductionin the mortality, confirming the benefit of its addition to patients withsepsis, severe sepsis and shock.
Primary Objective of the study is to evaluate the28-day mortality
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and females of age ≥18 years and ≤65 years.
- •2.Infection: Proved or suspected infection in at least one site: •lung •abdomen •genitourinary tract •other (blood, skin and soft tissue, central nervous system, bones and joints, cardiac system, catheter related infection) 3.Modified SIRS Criteria: Patient has to meet at least three of the following four criteria: •A core temperature of ≥ 38º C (100.4º F) or ≤ 36º C (96.8º F).
- •â€¢Heart rate of ≥90 beats/min, except in patients with a medical condition known to increase the heart rate or those receiving treatment that would prevent tachycardia.
- •â€¢Respiratory rate ≥20 breaths/min or PaCO2 of ≤32 mmHg or the use of mechanical ventilation for an acute respiratory process.
- •â€¢A white cell count of ≥12,000/mm3 or ≤4,000/mm3 or a differential count showing >10% immature neutrophils.
- •4.Criteria for Dysfunctional Organs or Systems: Patient has to meet at least one of the following six criteria: •For cardiovascular system dysfunction, the arterial systolic blood pressure (SBP) has to be ≤90 mmHg or the mean arterial pressure ≤70 mmHg for at least 1 hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a SBP of ≥90 mmHg or a mean arterial pressure of ≥70 mmHg. •For kidney dysfunction, urine output has to be <0.5 ml/kg of body weight/ hour for 1 hour, despite adequate fluid resuscitation.
- •â€¢For respiratory dysfunction, the ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) has to be ≤250 in the presence of other dysfunctional organs or systems or ≤200 if the lung is the only dysfunctional organ.
- •â€¢For hematologic dysfunction, the platelet count has to be <80,000/mm3 or to have decreased by 50% in the 3 days preceding enrolment.
- •â€¢In the case of unexplained metabolic acidosis, the pH has to be ≤7.30 or the base deficit has to be ≥ 5.0 mmol/L in association with a plasma lactate level that is >1.5 times the upper limit of the normal (ULN) value for the reporting laboratory.
- •â€¢For hepatic dysfunction, total bilirubin >1.5 mg/dL and/or Alanine Transaminase (ALT)/Aspartate Transaminase (AST) >3 times the upper limit of the normal value for the reporting laboratory.
- •5.Written informed consent by subject or LAR.
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study: 1.Patient with platelet count <30,000/mm
- •2.Conditions that increase the risk of bleeding.
- •3.Patient’s family, physician, or both not in favour of aggressive treatment of patient or presence of an advanced directive to withhold life-sustaining treatment.
- •4.Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end stage disease.
- •5.History of bone marrow, lung, liver, pancreas or small-bowel transplantation.
- •6.Patients with incurable malignancies with documented metastases.
- •7.Chronic renal failure requiring haemodialysis or peritoneal dialysis.
- •8.Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites.
- •9.Deep seated fungal infection or active tuberculosis.
- •10.History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
- •11.Neuromuscular disorders that impact breathing/spontaneous ventilation.
- •12.Quadriplegia.
- •13.Cardiac arrest in the past 30 days.
- •14.New York Heart Association functional Class III and IV due to heart failure or any disorder.
- •16.Allergy for Ulinastatin.
- •17.Pregnant or lactating females or females of child bearing potential who are not willing for using adequate methods of contraception.
- •18.Participation in another clinical study within 30 days prior to the study.
结局指标
主要结局
Percentage of subjects with reduction in mortality rate
时间窗: Day 28
次要结局
- 1.To evaluate the average length of hospital stay (days)(2.Percentage of subjects achieving subsidence of sepsis)
研究者
研究点 (4)
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