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To Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in Addition to Noradrenaline as a Vasopressor in Patients of Cirrhosis With Septic Shock

I

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Cirrhosis With Septic Shock

Treatments

Drug: Noradrenaline
Drug: Low dose terlipressin

Study type

Interventional

Funder types

Other

Identifiers

NCT02468063
ILBS-Cirrhosis-001

Details and patient eligibility

About

The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- The study is an open level study. The investigators will strictly follow the randomization table to give therapy as per the intervention arm.

  • Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and terlipressin along with noradrenaline to maintain the MAP >65mm Hg.

  • Intervention arm

    • Arm (A) - Noradrenaline
    • Arm (B) - Noradrenaline + low dose terlipressin

Enrollment

184 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18-70 yr
  • Cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs.

Exclusion criteria

  • ECG (ElectroCardiography)changes at presentation which exclude the use of vasopressin analouges
  • 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
  • Acute GI bleed
  • No Consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

184 participants in 2 patient groups

Noradrenaline + low dose terlipressin
Experimental group
Treatment:
Drug: Low dose terlipressin
Drug: Noradrenaline
Drug: Noradrenaline
Noradrenaline
Active Comparator group
Treatment:
Drug: Noradrenaline
Drug: Noradrenaline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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