a study comparing albumin given before versus during dialysis to prevent low blood pressure in liver cirrhosis patients

Pre- dialysis vs Intra-dialytic 20 percent Albumin in Cirrhosis Requiring Slow low efficiency dialysis or Isolated ultrafilteration : PILOT Randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113906

Enrollment

Registered

2026-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: HUMAN ALBUMIN 20 PERCENT: HUMAN ALBUMIN 20 PERCENT TO BE GIVEN DURING OR BEFORE DIALYSIS Intervention2: HUMAN ALBUMIN 20 PERCENT TIMING WHEN TO BE GIVEN: TIMING FOR INFUSION TO BE GIVE

Eligibility

Inclusion criteria

Inclusion criteria: Adults more than or equal to 18 years. Diagnosed cirrhosis with clinical volume overload as ascites or anasarca with or without pulmonary congestion. Acute kidney injury Planned for slow low efficiency dialysis or isolated ultrafiltration. Informed consent from patient or surrogate.

Exclusion criteria

Exclusion criteria: Refractory shock Active uncontrolled gastrointestinal bleeding Mechanical ventilation Suspected intracranial hypertension Anaphylaxis to albumin Imminent liver transplant in less than 24to 48 hour Patients receiving blood and blood products during slow low efficiency dialysis or isolated ultrafiltration. Patients on maintenance hemodialysis Patients who received albumin in last 24 hours Patients with cardiac involvement or cirrhotic cardiomyopathy

Design outcomes

Primary

Measure	Time frame
To determine the proportion of patients who achieve targeted ultrafilteraion rate without any safety failure No safety failure as defined by No new vasopressor and no more than or equal to 20 percent escalation in baseline vasopressor dose No intra-dialytic hypotension requiring vasopressor bolus/infusion or session termination No rescue fluids more than or equal to 500 mL crystalloids or more than or equal to 100 mL 20 percent albumin for hypotension Timepoint: during each dialysis session every 20 minutes	—

Measure

Time frame

To determine the proportion of patients who achieve targeted ultrafilteraion rate without any safety failure No safety failure as defined by No new vasopressor and no more than or equal to 20 percent escalation in baseline vasopressor dose No intra-dialytic hypotension requiring vasopressor bolus/infusion or session termination No rescue fluids more than or equal to 500 mL crystalloids or more than or equal to 100 mL 20 percent albumin for hypotension Timepoint: during each dialysis session every 20 minutes

—

Secondary

Measure	Time frame
To compare ultrafiltration achieved between the two albumin timing strategies. To assess hemodynamic tolerance, including intradialytic hypotension episodes & vasopressor requirement. To evaluate feasibility outcomes such as session completion, on-machine time, & reasons for interruption. To compare renal & metabolic parameters, including urine output, creatinine/urea changes, lactate, bicarbonate, & pH. Timepoint: during each dialysis session every 20 minutes	—

Measure

Time frame

To compare ultrafiltration achieved between the two albumin timing strategies. To assess hemodynamic tolerance, including intradialytic hypotension episodes & vasopressor requirement. To evaluate feasibility outcomes such as session completion, on-machine time, & reasons for interruption. To compare renal & metabolic parameters, including urine output, creatinine/urea changes, lactate, bicarbonate, & pH. Timepoint: during each dialysis session every 20 minutes

—

Countries

India

Contacts

Public Contactdr. nidhi yadav

institute of liver and biliary sciences

hsnephrology@gmail.com7999514306

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026