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Study seeks best fluid strategy for liver patients with sepsis

NCT ID NCT05059795

Knowledge-focused Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compared different methods to estimate how much fluid is needed in patients with liver cirrhosis or acute-on-chronic liver failure who also have sepsis and low blood pressure. Researchers enrolled 350 adults and looked at whether using ultrasound-guided fluid assessment or standard goal-directed therapy leads to better outcomes, like reaching a target blood pressure. The goal is to find the safest and most effective way to guide fluid treatment in this complex group of patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Albumin + electrolyte solution
What this could lead to
If successful, this could help doctors choose the best way to give fluids to liver disease patients with sepsis, potentially improving survival.
What could go wrong
This is a completed study comparing methods, not testing a new treatment. Results may not change practice immediately or apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

350 people

The number who actually took part.

Started

Feb 2020

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients 18-65 years age with cirrhosis of any etiology now presenting with sepsis induced hypotension

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure cirrhosis of liver Fibrosis infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute-on-chronic liver failure Cirrhosis, liver Sepsis

Contacts and locations

Locations

  • PGIMER

    Chandigarh, Chandigarh, 160012, India

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, 160012, India

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