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NCT Number: NCT02468063

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

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

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Key information

Conditions

Cirrhosis With Septic Shock

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose terlipressin

Drug

Terlipressin-2mg (low dose )

Noradrenaline

Drug

Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min

Primary outcomes

  1. Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs

    Time frame: 6 hours

Secondary outcomes

  1. Maintenance of target MAP (Mean Arterial Pressure)

    Time frame: 2 days

    MAP is Mean Arterial pressure SVR is Sustained Virologic Response

  2. Survival

    Time frame: 28 days

  3. Survival

    Time frame: 48 hours

  4. Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),

    Time frame: 2 years

  5. Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),

    Time frame: 2 years

  6. Effect on - AKI (Acute kidney Injury),

    Time frame: 2 years

  7. Effect on variceal bleed

    Time frame: 2 years

  8. Effect on rebound hypotension

    Time frame: 2 years

  9. Effect on organ failure

    Time frame: 2 years

  10. Length of ICU

    Time frame: 2 years

  11. Length of hospital stay.

    Time frame: 2 years

  12. Incidence of adverse events.

    Time frame: 2 years

  13. Predictors of adverse events.

    Time frame: 2 years

  14. SVR (Sustained Virologic Response) ≥600 at 48 hrs

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

A Prospective Study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2015
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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