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

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ClinicalTrials.gov Identifier: NCT01836224
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : October 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Shock

Arm Intervention/treatment
Active Comparator: Noradrenaline
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.
Drug: 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

Experimental: Terlipressin
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.
Drug: Terlipressin
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.




Primary Outcome Measures :
  1. The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg. [ Time Frame: 48 hrs ]

Secondary Outcome Measures :
  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. ]


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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:

  • 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)

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): NCT01836224


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01836224     History of Changes
Other Study ID Numbers: ILBS-Sepsis-01
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: December 2013
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