The Patient evaluated in Emergency room since admission and detailed history and clinical examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive Care Unit (ICU) in view of septic shock were included since onset of shock. Initial fluid resuscitation done and if the patient were no fluid responsive they were randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the primary objectives. At the same time the strict vitals monitoring and standard medical therapy for sepsis including antibiotics and other supportive therapy continued. The patients were followed up till discharge, death or up to 28days after enrollment into the protocol (whichever the longest). The detail methodology has been explained in column 14 later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Terlipressin (1.3mcg/min i.e 2mg over 24 hr to max of terlipressin 5.2mcg/min i.e. up to 8mg over 24hr) .The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure) \>65 .Terlipressin 2mg in 48ml,1ml=42mcg=0.67mg/min, max dose 8mg/day- 8ml/hr of infusion.
Noradrenaline 2amp (4000mcg in 50ml) at 6ml/hr = 7.5mcg/min and dose maximum 60mcg/min 24ml/hr double strength. The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure)\>65
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.
Time frame: 48 hrs
Mortality
Time frame: Day 3, Day 7 and Day 28
Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment)
Time frame: Within 28 days
Days free of vasopressors
Time frame: Within 28 days
Days free of ventilatory support
Time frame: Within 28 days
Days free of steroid
Time frame: Within 28 dyas
Length of stay
Time frame: Within 28 days
Incidence of serious adverse events.
Time frame: Within 28 days.
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