A clinical trial to study the effects of Ulinastatin as an adjuvant therapy in treatment of severe sepsis

Phase 4

• Conditions: Health Condition 1: null- Severe SepsisHealth Condition 2: R652- Severe sepsis

• Registration Number: CTRI/2012/11/003158
• Lead Sponsor: BHARAT SERUMS AND VACCINES LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Applicable
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified