Cirrhosis With Septic Shock
Conditions
Brief summary
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.
Interventions
DRUGTerlipressin
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.
DRUGNoradrenaline
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
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient of cirrhosis or ACLF (Acute on Chronic Liver Failure) with septic shock (defined later). * Age 18-70yrs * An informed consent from the patient or relative
Exclusion criteria
* Pronounced cardiac dysfunction( valvular heart disease, coronary artery disease), * Acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. Reynaud's syndrome or related diseases). * Pregnancy * Previous history of transplantation on immunosuppressant. * Acute gastrointestinal bleed.(defined later)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg. | 48 hrs |
Secondary
| Measure | Time frame |
|---|---|
| Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment) | Within 28 days |
| Days free of vasopressors | Within 28 days |
| Days free of ventilatory support | Within 28 days |
| Mortality | Day 3, Day 7 and Day 28 |
| Length of stay | Within 28 days |
| Incidence of serious adverse events. | Within 28 days. |
| Days free of steroid | Within 28 dyas |
Countries
India
Outcome results
None listed