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OpenTrials
Completed

NCT Number: NCT01836224

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

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.

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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

  • 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)

Treatment and study plan

Terlipressin

Drug

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

Drug

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

Primary outcomes

  1. The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.

    Time frame: 48 hrs

Secondary outcomes

  1. Mortality

    Time frame: Day 3, Day 7 and Day 28

  2. Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment)

    Time frame: Within 28 days

  3. Days free of vasopressors

    Time frame: Within 28 days

  4. Days free of ventilatory support

    Time frame: Within 28 days

  5. Days free of steroid

    Time frame: Within 28 dyas

  6. Length of stay

    Time frame: Within 28 days

  7. Incidence of serious adverse events.

    Time frame: Within 28 days.

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

A Prospective Open Label Randomized Non Inferiority Trial to Compare the Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2013
Registry last updated
Nov 22, 2016

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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