A Phase IV study to evaluate safety and efficacy of Intravenous Ulinastatin versus Placebo administered along with standard supportive care
- Conditions
- Health Condition 1: null- Severe Sepsis
- Registration Number
- CTRI/2016/06/007046
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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).
•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.
•Respiratory rate >=20 breaths/min or PaCO2 of <=32 mmHg or the use of mechanical ventilation for an acute respiratory process.
•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.
•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.
•For hematologic dysfunction, the platelet count has to be <80,000/mm3 or to have decreased by 50% in the 3 days preceding enrolment.
•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.
•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.
Subjects who meet any of the following criteria will be excluded from the study:
1.Patient with platelet count <30,000/mm3.
2.Conditions that increase the risk of bleeding.
3.Patientâ??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.
15.Burns over >30% of body surface area.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method