Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis With Septic Shock

Treatments: Drug: Noradrenaline; Drug: Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT01836224

ILBS-Sepsis-01

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Noradrenaline

Active Comparator group

Description:

Noradrenaline: 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.

Treatment:

Drug: Noradrenaline

Terlipressin

Experimental group

Description:

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.

Treatment:

Drug: Terlipressin