Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Fluids plus norepinephrine: I.V Norepinephrine 0.05 microgram/kg/min along with the normal or ringer lactate (upto 30ml/kg) till hemodynamic goal of mean arterial pressure of more than
Sponsors
All India Institute Of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1)Adults aged more than or equal to 18 years presenting to the emergency room with hypotension determined by mean arterial blood pressure lower than 65 mm Hg 2)Patients with features of suspected or confirmed sepsis 3)Patients with serum lactate more than 2 mmol/L 4)Patients with the Modified Early Warning Score (MEWS) more than or equal to 5 5)Legally authorised representative willing to give valid consent
Exclusion criteria
Exclusion criteria: 1)Patients aged less than 18 years on the day of admission. 2)Patients administered more than 3 L of IV fluids before enrollment 3)Pregnancy or Lactation: Pregnant or breastfeeding women are excluded due to potential risks to the fetus or infant 4)Known allergy or hypersensitivity to norepinephrine 5)Known contraindications to aggressive fluid resuscitation such as heart failure with reduced ejection fraction or severe pulmonary edema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare shock control rate at 6 hours from the time of randomization between intervention group and control groupTimepoint: Shock control rate at 6 hours from the time of randomization which is determined by sustained mean arterial pressure of more than or equal to 65mm Hg, together with evidence of adequate tissue perfusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare requirement of mechanical ventilator support in intervention group & control group within six hoursTimepoint: Within 6 hours from the time of randomization;To compare mortality upto 7 days and 28 days in both the groupsTimepoint: Upto 7 days and 28 days from the time of randomization;Documenting & comparing any adverse events such as extravasation of norepinephrine, new onset arrhythmias, acute intestinal ischemia, peripheral ischemia within 6 hours in both intervention group & control groupTimepoint: Within 6 hours from the time of randomization | — |
Countries
India
Contacts
Public ContactDr KAPIL DEV SONI
All India Institute Of Medical Sciences, New Delhi
Outcome results
None listed