Clinical trial

To Compare the Effectiveness of Various Methods of Estimating Volume Resuscitation in Patients With Cirrhosis With Sepsis Induced Hypotension

Name
Im/2019/2917
Description
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.
Trial arms
Trial start
2020-02-01
Estimated PCD
2024-07-01
Trial end
2024-09-10
Status
Recruiting
Treatment
Albumin
Type of resuscitation fluid, dose and use of inotrope
Arms:
Cirrhosis/ACLF of any etiology
Other names:
Crystalloid
Size
300
Primary endpoint
Achievement of Mean Arterial pressure >65 mmHg
At the end of 4 hours since admission (time zero)
Eligibility criteria
Inclusion Criteria: 1. Clinical/Imaging or Biopsy proven liver cirrhosis of any etiology 2. Hypotension (MAP \<65mmHg or SBP \<90mmHg) 3. 18-65 yrs of age Exclusion Criteria: 1. Already received colloid or 2 litres of fluid within the first 2 hours of presentation, without echocardiographic assessment. 2. Already on vasopressors/inotropes 3. Severe pre-existing cardiopulmonary disease 4. Acute Respiratory Distress Syndrome (ARDS) 5. Active bleeding like variceal bleed 28 6. Cerebrovascular events 7. Chronic renal disease - End Stage Renal Disease (ESRD)/ patient on renal replacement therapy 8. Admission to ICU following liver transplantation, burns, cardiac surgery 9. Brain death or likely brain death within 24 hours 10. Previous adverse reaction to human albumin solution 11. Pregnant or lactating women 12. Informed consent refused by patient or attendants
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and Urine Samples'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-04-25

1 organization

1 product

4 indications

Product
Albumin
Indication
Cirrhosis
Indication
Liver
Indication
Sepsis