To Compare the Effectiveness of Various Methods of Estimating Volume Resuscitation in Patients With Cirrhosis With Sepsis Induced Hypotension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 350
- Locations
- 2
- Primary Endpoint
- Achievement of Mean Arterial pressure >65 mmHg
Study Overview
Brief Summary
In critically ill patients with liver disease like cirrhosis or ACLF, fluid therapy needs to be instituted after identification of patients who will be fluid responsive and initiate appropriate inotropes early to prevent the mortality associated with fluid overload.
The parameters and methodology used for assessing fluid responsiveness have been studied earlier, but the optimum method is not established. Existing recommendations based on data regarding fluid responsiveness and choice of fluid for resuscitation from intensive care units in general cannot be applied to those with liver disease as the hemodynamic alterations that occur with liver disease, presence of hypoalbuminemia at baseline and presence of cardiac dysfunction interfere with the conventional methods of fluid status assessment, fluid responsiveness as well as the response to different types of resuscitation fluids.
Therefore the investigators attempt to compare various methods to estimate current intravascular volume status of patient which could be helpful in guiding fluid therapy.
Detailed Description
Objectives:
- To compare the accuracy of central venous pressure and inferior vena cava dynamic assessment and lactate clearance for estimating adequacy of fluid resuscitation in patients with cirrhosis with sepsis induced hypotension .[Time Frame at enrolment, 6 hours, 24 hours]
- Predictors of all-cause mortality at Day 7 and day 28. [Time Frame Day 7 and Day 28]
PATIENTS AND METHODS Study Design: A Prospective observational study
Case Definition:
Cirrhosis will be defined by - "clinical features consistent with chronic liver disease (CLD) including a consistent history as well as a documented complication of CLD (i.e., ascites, varices, hepatic encephalopathy) and/or imaging results consistent with cirrhosis and/or liver histologic findings consistent with cirrhosis" ACLF will be defined as per EASL criteria with documentation of organ failures.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical/Imaging or Biopsy proven liver cirrhosis of any etiology
- •Hypotension (MAP <65mmHg or SBP <90mmHg)
- •18-65 yrs of age
Exclusion Criteria
- •Already received colloid or 2 litres of fluid within the first 2 hours of presentation, without echocardiographic assessment.
- •Already on vasopressors/inotropes
- •Severe pre-existing cardiopulmonary disease
- •Acute Respiratory Distress Syndrome (ARDS)
- •Active bleeding like variceal bleed 28
- •Cerebrovascular events
- •Chronic renal disease - End Stage Renal Disease (ESRD)/ patient on renal replacement therapy
- •Admission to ICU following liver transplantation, burns, cardiac surgery
- •Brain death or likely brain death within 24 hours
- •Previous adverse reaction to human albumin solution
- •Pregnant or lactating women
- •Informed consent refused by patient or attendants
Arms & Interventions
Cirrhosis/ACLF of any etiology
Intervention: Albumin + electrolyte solution (Drug)
Cirrhosis/ACLF of any etiology
Intervention: POCUS guided fluid resuscitation (Diagnostic Test)
Outcomes
Primary Outcomes
Achievement of Mean Arterial pressure >65 mmHg
Time Frame: At the end of 4 hours since admission (time zero)
Secondary Outcomes
- Mortality(Day 28)
- Documentation of Cardiac index(Time zero at admission)
- Requirement of vasopressors(At the end of 24 hours of admission)
- Duration of hospital stay(Total duration of admission as a hospital inpatient, assessed till 28 days)
- Documentation of POCUS systemic vascular resistance index at 6h(at 6hours of admission)
- Volume of fluid infused(At the end of 72 hours of admission)
- Incidence of new organ dysfunction (encephalopathy, coagulation failure, respiratory failure)(Day 7)
- Duration of ICU stay(Total duration of ICU stay in days)
- Documentation of Cardiac index at 72h(At 72 hours of admission)
- Incidence of Acute Kidney Injury(Day 7)
- Documentation of Cardiac index at 24h(At 24 hours of admission)
- Documentation of POCUS systemic vascular resistance index at 72h(at 72hours of admission)
- Documentation of IVC dynamics(at 72hours of admission)
- Documentation of Cardiac index at 6h(At 6 hours of admission)
- Documentation of Cardiac index at 48h(At 48 hours of admission)
- Documentation of POCUS systemic vascular resistance index(Time zero at admission)
- Documentation of POCUS systemic vascular resistance index at 24h(at 24hours of admission)
- Documentation of POCUS systemic vascular resistance index at 48h(at 48hours of admission)
Investigators
Madhumita Premkumar
Assitant Professor
Post Graduate Institute of Medical Education and Research, Chandigarh