Point-of-care Echocardiogram (POCUS) Guided Resuscitation Versus Conventional Goal- Directed Therapy in the Management of Cirrhosis With Severe Sepsis or Septic Shock: A Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: * The investigators will conduct an ICU based randomised controlled feasibility trial comparing two measures of resuscitation: Echocardiography (ECHO) Guided septic shock resuscitation vs. a modified Goal-Directed Fluid Therapy (GDT) as recommended by sepsis guidelines which use protocol fluids. * The study will validate the role of POC-Echo parameters as volume assessment tools (cardiac index, systemic vascular resistance index) to determine endpoints of fluid resuscitation and need for vasopressors. * Lastly, the study aims to determine the presence of CCM in this population, and its impact on clinical outcomes. Methods POC-ECHO will be done within 1 hours of admission to the liver ICU and at 24h, 48 h and 72 hours in patients with cirrhosis with systolic blood pressure of \<90 mmHg or a mean arterial pressure \<65 mmHg. Resuscitation target is maintenance of MAP ≥65 mmHg with use of fluids and/or vasopressors. Clinical, cardiac biomarkers, and survival data based on resuscitation fluids will be prospectively collected. CCM will be defined as per CCM Consortium (2020) criteria. Expected outcome. The key questions to be answered in the resuscitation of critically ill patients with cirrhosis and sepsis induced hypotension are: 1. What should be best method of ensuring adequate fluid resuscitation i.e. fluid resuscitation protocol? 2. Which measurable clinical parameter can be used to determine adequacy of fluid resuscitation, and as a predictor of mortality outcomes at 7 and 28 days? 3. Whether early fluid resuscitation translates into better clinical outcome in decreasing duration of hospital and intensive care unit (ICU) stay, prevention of AKI and prevention of secondary sepsis?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Critically ill patient with cirrhosis of any etiology

• Sepsis-related Hypotension (MAP \<65mmHg or SBP \<90mmHg)

• 18-65 yrs of age -

Locations
Other Locations
India
PGIMER Chandigarh
RECRUITING
Chandigarh
Contact Information
Primary
Dr Madhumita Premkumar, DM
drmadhumitap@gmail.com
7087003409
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 140
Treatments
Experimental: ECHO arm
Other Names: Point of Care- Echo-cardiogram,POCUS Description: • The patients in septic shock with MAP\< 65mmHg, with IVC diameter \<18mm and IVCCI≥40% in spontaneously breathing patients, would be regarded as fluid depleted state and will be given a fluid challenge with 250-500 ml of balanced salt solution. Those who increment cardiac index by 15% will be continued on fluid boluses with BSS and 5% albumin will be started as ongoing resuscitation within 1 h, which is a standard fluid of choice in patients with cirrhosis soon after the bolus BSS is infused. Fluids will be administered as per periodic POCUS with cardiac US targets, IVC, IJV indices, delta Velocity time integral, and maintenance of MAP\>65 mmHg. In the Intervention arm (ECHO) arm, we propose a dynamic Cardiac ultrasound target-based fluid resuscitation strategy.
Active_comparator: Conventional goal directed therapy. (CGDT)
Fixed Target Strategy Fluid boluses would be administered until a central venous pressure (CVP) of 8-10 mmHg is achieved. Till the central line is placed, the shock index (heart rate/ systolic blood pressure) will be used instead of the CVP and IVC indices. Thus fluids (500 ml balanced salt solution followed by 5% albumin) will be administered for a shock index ≥1 and till CVP is placed. • When CVP goal is achieved vasopressors will be started to target MAP ≥ 65mmHg. Once MAP target is achieved, ScVO2 ≥70% and lactate clearance \>10% will be targeted. • If ScVO2 is \<70% and lactate clearance is \<10%, noradrenaline will be started and titrated upwards. take it up to a maximum dose. • Second choice of pressor agent will be vasopressin. • Thus. CGDT group targets CVP, MAP, followed by ScVO2 ≥70% and lactate clearance .
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov