Skip to main content
OpenTrials
Completed

NCT Number: NCT03145168

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Target Mean Arterial Pressure

Other

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

Low Target Mean Arterial Pressure

Other

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

Primary outcomes

  1. Survival in both groups

    Time frame: 28 days

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: 3 months

  2. Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy

    Time frame: 3 months

  3. Duration of Intensive Care Unit /Hospital stay

    Time frame: 3 months

  4. Reversal of shock in both groups

    Time frame: Day 5

  5. Acute Kidney Injury in both groups.

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 9, 2017
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.