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

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Cirrhosis

Treatments

Other: High Target Mean Arterial Pressure

Other: Low Target Mean Arterial Pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT03145168

ILBS-Cirrhosis-08

Details and patient eligibility

About

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

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Critically ill cirrhotics with septic shock

Exclusion criteria

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