linastatin post marketing study on patients suffering with severe sepsis

Phase 4

Completed

Conditions: Health Condition 1: R652- Severe sepsis

Registration Number: CTRI/2016/04/006805

Lead Sponsor: Bharat Serums and Vaccines Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Age between 18 years and 65 years (both inclusive)

2) Infection Criteria:

Patient should have a known infection or a suspected infection, as evidenced by one or more of the following:

a)White cells

b)Perforated viscus

c)Pneumonia

d)Bacterial infection

e)Other infections

3) Modified SIRS Criteria:

Patient has to meet two of the following four criteria:

1.Fever

2.Abnormal heart rate

3.Abnormal respiratory rate

4.Abnormal white cell count

4) Criteria for Severe sepsis:

Patient has to meet at least one of the following nine criteria

1.Abnormal blood pressure

2.Abnormal Urine output

3.Abnormal Creatinine

4.Acute lung injury

5.Acute lung injury with pneumonia

6.Abnormal lactate level

7.Abnormal total bilirubin

8.Abnormal platelet count

9.Coagulopathy

Exclusion Criteria

1.Pregnancy or breast-feeding

2. Age < 18yr or > 65 years

3. Patient’s family, physician, or both not in favor 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. Moribund state in which death is perceived to be imminent (= 24 hours)

6. History of bone marrow, lung, liver, pancreas or small-bowel transplantation

7. Participation in any other investigational study within 30 days before the current study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. 28-day mortality <br/ ><br>2. Length of hospital stay (days) <br/ ><br>Timepoint: 1. 28-day mortality <br/ ><br>2. Length of hospital stay (days) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Length of ICU stay (days) <br/ ><br>2. 90-Day Mortality <br/ ><br>3. Incidence of new onset organ failure <br/ ><br>4. Duration of assisted ventilation, if any. <br/ ><br>Timepoint: 1. when shifted out of ICU <br/ ><br>2. Day 90 <br/ ><br>3. Any time during the study period <br/ ><br>4. any time during the study period