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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

Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis With Septic Shock

Intervention: Low dose terlipressin (Drug); Noradrenaline (Drug); Noradrenaline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Institute of Liver and Biliary Sciences, India

Official(s) and/or principal investigator(s):
Vikash Prakash, MD, Principal Investigator, Affiliation: Institute of Liver and Biliary Sciences

Overall contact:
Vikash Prakash, MD, Phone: +91-46300000, Email: vp_vmmc@yahoo.co.in

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Maintenance of target MAP (Mean Arterial Pressure)

Survival

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Vikash Prakash, MD, Phone: +91-46300000, Email: vp_vmmc@yahoo.co.in

Institute of Liver and Biliary Sciences, New Delhi, Delhi 110070, India; Recruiting
Additional Information

Starting date: May 2015
Last updated: June 5, 2015

Page last updated: August 23, 2015

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