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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03145168
Enrollment
150
Registered
2017-05-09
Start date
2018-09-19
Completion date
2021-03-18
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

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

Interventions

OTHERHigh Target Mean Arterial Pressure

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

OTHERLow Target Mean Arterial Pressure

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

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Survival in both groups28 days

Secondary

MeasureTime frame
Duration of mechanical ventilation3 months
Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy3 months
Duration of Intensive Care Unit /Hospital stay3 months
Reversal of shock in both groupsDay 5
Acute Kidney Injury in both groups.Day 5

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026