Clinical trial NCT03145168: High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics
Official title: High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics -A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Survival in both groups
timeFrame: 28 days
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 3 months
measure: Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy
timeFrame: 3 months
measure: Duration of Intensive Care Unit /Hospital stay
timeFrame: 3 months
measure: Reversal of shock in both groups
timeFrame: Day 5
measure: Acute Kidney Injury in both groups.
timeFrame: Day 5
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: