Health Condition 1: I958- Other hypotension Health Condition 2: A419- Sepsis, unspecified organism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patient (more than equal to 18 years) with sepsis induced hypotension or septic shock as per Sepsis 3 consensus conference
Exclusion criteria
Exclusion criteria: 1. Received more than 10ml/kg of intravenous crystalloids before randomization in last 3 hours 2. Do not resuscitate status 3. Anticipated surgery or acute hemodialysis procedure to start during the first 3 hour period 4. Child B-C Cirrhosis 5. Pregnancy 6. Treating Physicians feel use of fluid bolus or vasopressor is strongly indicated or contraindicated 7. Age less than 18 years 8. Inability to take consent from surrogate 9.Vasopressors stopped less than 24 hours before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality within 28 days after randomizationTimepoint: 28 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Days free from Renal Replacement therapy (within 28 days after randomization)Timepoint: till day 28 or ICU discharge or Death, whichever come first;Days free from vasopressor use (within 28 days after randomization).Timepoint: till day 28 or ICU discharge or Death, whichever come first;Death during period of early resuscitation (within 3 hours)Timepoint: upto 3 hrs post randomisation;Lactate reduction by 3rd hourTimepoint: upto 3 hrs post randomisation;Length of ICU Stay.Timepoint: till discharge from Intensive care unit after enrollment;Number of days free from ventilator use (within 28 days after randomization).Timepoint: till day 28 or ICU discharge or Death, whichever come first;Time to CRT normalizationTimepoint: till day 28 or ICU discharge or Death, whichever come first | — |
Countries
India
Contacts
Tata Memorial Hospital