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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

Primary Purpose

Cirrhosis With Septic Shock

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Low dose terlipressin

Noradrenaline

About this trial

This is an interventional treatment trial for Cirrhosis With Septic Shock

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Noradrenaline + low dose terlipressin

Noradrenaline

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maintenance of target MAP (Mean Arterial Pressure)

MAP is Mean Arterial pressure SVR is Sustained Virologic Response

Survival

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

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

Effect on - AKI (Acute kidney Injury),

Effect on variceal bleed

Effect on rebound hypotension

Effect on organ failure

Length of ICU

Length of hospital stay.

Incidence of adverse events.

Predictors of adverse events.

SVR (Sustained Virologic Response) ≥600 at 48 hrs

Full Information

NCT ID

NCT02468063

First Posted

May 22, 2015

Last Updated

November 2, 2017

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT02468063

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 1, 2015 (Actual)

Primary Completion Date

May 31, 2017 (Actual)

Study Completion Date

May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis With Septic Shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

184 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Noradrenaline + low dose terlipressin

Arm Type

Experimental

Arm Title

Noradrenaline

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Low dose terlipressin

Intervention Description

Terlipressin-2mg (low dose )

Intervention Type

Drug

Intervention Name(s)

Noradrenaline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Noradrenaline

Intervention Description

Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min

Primary Outcome Measure Information:

Title

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

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Maintenance of target MAP (Mean Arterial Pressure)

Description

MAP is Mean Arterial pressure SVR is Sustained Virologic Response

Time Frame

2 days

Title

Survival

Time Frame

28 days

Title

Survival

Time Frame

48 hours

Title

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

Time Frame

2 years

Title

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

Time Frame

2 years

Title

Effect on - AKI (Acute kidney Injury),

Time Frame

2 years

Title

Effect on variceal bleed

Time Frame

2 years

Title

Effect on rebound hypotension

Time Frame

2 years

Title

Effect on organ failure

Time Frame

2 years

Title

Length of ICU

Time Frame

2 years

Title

Length of hospital stay.

Time Frame

2 years

Title

Incidence of adverse events.

Time Frame

2 years

Title

Predictors of adverse events.

Time Frame

2 years

Title

SVR (Sustained Virologic Response) ≥600 at 48 hrs

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vikash Prakash, MD

Organizational Affiliation

Institute of Liver and Biliary Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Liver and Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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