High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
High Target Mean Arterial Pressure
Low Target Mean Arterial Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Target Mean Arterial Pressure
Low target Mean Arterial Pressure
Arm Description
Outcomes
Primary Outcome Measures
Survival in both groups
Secondary Outcome Measures
Duration of mechanical ventilation
Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy
Duration of Intensive Care Unit /Hospital stay
Reversal of shock in both groups
Acute Kidney Injury in both groups.
Full Information
NCT ID
NCT03145168
First Posted
April 10, 2017
Last Updated
September 20, 2022
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03145168
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
March 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Target Mean Arterial Pressure
Arm Type
Experimental
Arm Title
Low target Mean Arterial Pressure
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
High Target Mean Arterial Pressure
Intervention Description
High target group (80-85 mm of Hg).
Intervention Type
Other
Intervention Name(s)
Low Target Mean Arterial Pressure
Intervention Description
Low target MAP group (60-65mm Hg).
Primary Outcome Measure Information:
Title
Survival in both groups
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Time Frame
3 months
Title
Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy
Time Frame
3 months
Title
Duration of Intensive Care Unit /Hospital stay
Time Frame
3 months
Title
Reversal of shock in both groups
Time Frame
Day 5
Title
Acute Kidney Injury in both groups.
Time Frame
Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics
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