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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468063
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Cirrhosis With Septic Shock Drug: Low dose terlipressin Drug: Noradrenaline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Shock

Arm Intervention/treatment
Experimental: Noradrenaline + low dose terlipressin Drug: Low dose terlipressin
Terlipressin-2mg (low dose )

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

Active Comparator: Noradrenaline Drug: Noradrenaline
Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min




Primary Outcome Measures :
  1. Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468063


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Vikash Prakash, MD Institute of Liver and Biliary Sciences
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02468063    
Other Study ID Numbers: ILBS-Cirrhosis-001
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Shock, Septic
Liver Cirrhosis
Shock
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Terlipressin
Norepinephrine
Antihypertensive Agents
Vasoconstrictor Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents