High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics

NCT03145168 | Completed

• 1 other identifier: ILBS-Cirrhosis-08
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design:

• A randomized controlled study.
• The study will be conducted on patients admitted to Department of Hepatology from April 2017 to October 2017 at ILBS, New Delhi
• Study group will comprise of patients critically ill cirrhotics with septic shock All included patients would be randomised to low target MAP group (60-65mm Hg) or high target group (80-85 mm of Hg). Patients older than 18 years of age will be enrolled if they have septic shock that is refractory to fluid resuscitation and if they required vasopressors (norepinephrine or epinephrine or terlipressin) at a minimum infusion rate of 0.1 μg per kilogram per minute. Standard criteria will be considered to define refractoriness to fluids. The target MAP would be maintained for a max. of 5 days or until recovery or shock and or AKI. In the high-target group, a reduction in vasopressor doses to maintain a mean arterial pressure of 65 to 70 mm Hg will be done in case of any of the prespecified serious adverse events that could potentially be related to an increased rate of vasopressor infusion occurred. These events could be: clinically relevant bleeding (i.e., transfusion requirements of at least 2 units of packed red cells), myocardial infarction (defined as typical electrocardiographic changes, with a concomitant increase in troponin, and segmental echocardiographic hypokinesia or akinesia, with the infarction confirmed, when possible, by means of coronary angiography), major ventricular arrhythmia, poorly tolerated supraventricular arrhythmia, mesenteric ischemia, and distal-limb ischemia.
• Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP\>=65 mm of Hg and having a serum lactate \>2 mmol/L despite adequate volume resuscitation

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Survival in both groups

  28 days

Secondary Outcomes (5)

• Duration of mechanical ventilation

  3 months

• Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy

  3 months

• Duration of Intensive Care Unit /Hospital stay

  3 months

• Reversal of shock in both groups

  Day 5

• Acute Kidney Injury in both groups.

  Day 5

Study Arms (2)

High Target Mean Arterial Pressure

EXPERIMENTAL

Other: High Target Mean Arterial Pressure

Low target Mean Arterial Pressure

ACTIVE COMPARATOR

Other: Low Target Mean Arterial Pressure

Interventions

High Target Mean Arterial Pressure OTHER

High target group (80-85 mm of Hg).

High Target Mean Arterial Pressure

Low Target Mean Arterial Pressure OTHER

Low target MAP group (60-65mm Hg).

Low target Mean Arterial Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill cirrhotics with septic shock

You may not qualify if:

• Patients with age less than 18 years
• Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
• Pregnancy
• Chronic kidney disease on hemodialysis
• Extremely moribund patients with an expected life expectancy of less than 24 hours
• Failure to give informed consent from family members.
• Hemodynamic instability requiring very high dose of vasopressors

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• Maiwall R, Rao Pasupuleti SS, Hidam AK, Kumar A, Tevethia HV, Vijayaraghavan R, Majumdar A, Prasher A, Thomas S, Mathur RP, Kumar G, Sarin SK. A randomised-controlled trial (TARGET-C) of high vs. low target mean arterial pressure in patients with cirrhosis and septic shock. J Hepatol. 2023 Aug;79(2):349-361. doi: 10.1016/j.jhep.2023.04.006. Epub 2023 Apr 23.

  PMID: 37088310 DERIVED

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: May 9, 2017
• Study Start: September 19, 2018
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

IN (1)