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

Cirrhosis Clinical Trial

Official title:

High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics -A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145168
• Other study ID #: ILBS-Cirrhosis-08
• Status: Completed
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: March 18, 2021

Study information

• Verified date: September 2022
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Critical Illness
• Shock, Septic

Intervention

Other:
• High Target Mean Arterial Pressure
High target group (80-85 mm of Hg).
• Low Target Mean Arterial Pressure
Low target MAP group (60-65mm Hg).

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in both groups		28 days
Secondary	Duration of mechanical ventilation		3 months
Secondary	Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy		3 months
Secondary	Duration of Intensive Care Unit /Hospital stay		3 months
Secondary	Reversal of shock in both groups		Day 5
Secondary	Acute Kidney Injury in both groups.		Day 5