CTRI/2012/11/003158Not Applicable4 期
A Phase IV, Prospective, Multicentric, Double-blind, Comparative, Clinical Study To Compare The Efficacy And Safety Of Intravenous Ulinastatin versus Placebo Alongwith Standard Supportive Care In Subjects With Severe Sepsis
试验速览
- 阶段
- 4 期
- 状态
- Not Applicable
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Inclusion Criteria
- •The following criteria should be checked at the time of study entry:
- •1) Age between 18 and 75 years (both inclusive) & weight <135kg
- •2) Infection Criteria:
- •Patient has to have a known infection or a suspected infection, as evidenced by one or more of the following:
- •a)White cells in a normally sterile body fluid
- •b)Perforated viscous
- •c)Radiographic evidence of pneumonia in association with the production of purulent sputum
- •d)A condition associated with a high risk of bacterial infection (e.g., ascending cholangitis). Restrict only to bacterial sepsis. DONOT include ARDS cases due to malaria, dengue or leptospirosis
- •3) Modified SIRS Criteria:
- •Patient has to meet at least three of the following four Criteria:
- •a)A core temperature of >= 38º C (100.4º F) or <= 36º C (96.8º F)
- •b)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
- •c)Respiratory rate >= 20 breaths/min or PaCO2 of <= 32 mm Hg or the use of mechanical ventilation for an acute respiratory process
- •d)A white cell count of >= 12,000/mm3 or <= 4,000/mm3 or a differential count showing > 10 percent immature neutrophils.
- •4) Criteria for Dysfunctional Organs or Systems:
- •Patients has to meet at least one of the following five criteria
- •a)For cardiovascular system dysfunction, the arterial systolic blood pressure has to be <= 90 mm Hg or the mean arterial pressure <= 70 mm Hg for at least 1 hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure of >= 90 mm Hg or a mean arterial pressure of >= 70 mm Hg.
- •b)For kidney dysfunction, urine output has to be < 0.5ml/kg of body weight/hr for 1 hour, despite adequate fluid resuscitation
- •c)For respiratory dysfunction, the ratio of PaO2 to FiO2 has to be <= 250 in the presence of other dysfunctional organs or systems or <= 200 if the lung is the only dysfunctional organ.
- •d)For hematologic dysfunction, the platelet count has to be < 80,000/mm3 or to have decreased by 50 percent in the 3 days preceding enrollment.
- •e)In the case of unexplained metabolic acidosis, the pH has to be <= 7.30 or the base deficit has to be >= 5.0 mmol/liter in association with a plasma lactate level that is > 1.5 times the upper limit of the normal value for the reporting laboratory.
- •f)For hepatic dysfunction, total bilirubin > 1.5 mg/dL and/or ALT/AST >3 times the upper limit of the normal value for the reporting laboratory
排除标准
- •1. Pregnancy or breast-feeding.
- •2. Age less than 18 years or more than 75 years or weight 135 kg.
- •3. Platelet count 30,000/mm3.
- •4. Conditions that increase the risk of bleeding.
- •5. Patientâ??s family, physician, or both not in favor of aggressive treatment of patient or presence of an
- •advanced directive to withhold life-sustaining treatment.
- •6. Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly
- •controlled neoplasm or other end stage disease.
- •7. Moribund state in which death was perceived to be imminent. (<= 24 hours)
- •8. History of bone marrow, lung, liver, pancreas or small-bowel transplantation.
- •9. Chronic renal failure requiring hemodialysis or peritoneal dialysis.
- •10. Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites
- •11. Participation in another investigational study within 30 days before the current study.
研究者
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