Assessing fluid resuscitation methods in patients with cirrhosis and sepsis
To Compare the Effectiveness of Various Methods of Estimating Volume Resuscitation in Patients With Cirrhosis With Sepsis Induced Hypotension
This study is testing different ways to see how much fluid patients with cirrhosis and sepsis need to help them recover better and avoid serious complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 2 sites (Chandigarh and 1 other locations) |
| Trial ID | NCT05059795 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of various methods for estimating fluid responsiveness in critically ill patients suffering from cirrhosis and sepsis-induced hypotension. The study will compare central venous pressure, inferior vena cava dynamics, and lactate clearance to determine the best approach for fluid resuscitation. By identifying patients who are likely to benefit from fluid therapy, the study seeks to improve outcomes and reduce mortality associated with fluid overload. The research will involve monitoring patients at enrollment, 6 hours, and 24 hours, as well as assessing mortality predictors at Day 7 and Day 28.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with clinically or imaging-proven cirrhosis and hypotension.
Not a fit: Patients with severe pre-existing cardiopulmonary disease or those who have already received significant fluid resuscitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fluid management strategies for patients with liver disease, potentially reducing mortality rates.
How similar studies have performed: While there have been studies on fluid resuscitation in general, this specific approach tailored for cirrhosis and sepsis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandigarh and 1 other locations
- Pgimer — Chandigarh, India (Recruiting)
- Postgraduate Institute of Medical Education and Research — Chandigarh, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.