Low-dose Albumin Infusion for the Prevention of Paracentesis Induced Circulatory Dysfunction (PICD), After Large Volume Paracentesis (LVP) in Decompensated Cirrhosis Liver.

NCT06892535 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: 4794BSMMU/2024/1784
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract for thesis protocol. Background: Paracentesis induced circulatory dysfunction (PICD) is a common complication of large volume paracentesis in cirrhotic patients, which can lead to renal impairment, hyponatremia, and increased mortality. Albumin infusion is recommended to prevent PICD, but the optimal dose is unclear. We aim to compare the efficacy of low dose albumin infusion versus standard dose of albumin in preventing PICD in cirrhotic patients. Material and methods: We will conduct a randomized controlled trial with two arms: low dose albumin infusion (2g per liter of ascitic fluid removed) versus standard dose albumin infusion (6g per liter of ascitic fluid removed). Patients with liver cirrhosis undergoing large volume paracentesis (\>5 L) with serum creatinine \<1.5 mg/dL and no signs of infection will be included in the study. Sample size calculation: Based on previous studies, group sample size will be 26 and will achieve 80.749% power to reject null hypothesis. As per availability, 30 participants will be included in each group, with a total number of 60 for this trial. Outcome of the study: The primary outcome is the incidence of paracentesis induced circulatory dysfunction (PICD) in both groups, (Low dose albumin and standard dose of albumin), 7 days after paracentesis. The secondary outcomes are renal failure, hyponatremia, hepatic encephalopathy, hepatorenal syndrome, and length of hospital stay. Conclusion: This trial will provide evidence on whether low dose albumin infusion is as effective as standard dose albumin infusion in preventing PICD in cirrhotic patients. This could have implications for reducing the cost and optimal effective dose of albumin therapy, as well as improving the outcomes of patients with ascites.

Conditions

Paracentesis-Induced Circulatory Dysfunction

Keywords

Low dose albumin infusion for PICD prevention after LVP in Decompensated cirrhosis

Outcome Measures

Primary Outcomes (1)

• The primary outcome

  The primary outcome is the incidence of PICD in both groups (low dose albumin and standard dose albumin), 7 days after paracentesis.

  6th day

Secondary Outcomes (1)

• The secondary outcomes

  6th day

Study Arms (1)

Albumin infusion, 6gm/L of ascitic fluid aspiration.

ACTIVE COMPARATOR

Drug: Albumin infusion, 2g/L of ascitic fluid aspiration.

Interventions

Albumin infusion, 2g/L of ascitic fluid aspiration. DRUG

Albumin infusion lower than the standard dose, either 2g/L or 4g/L of ascitic fluid aspiration is termed as low dose.

Albumin infusion, 6gm/L of ascitic fluid aspiration.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhotic patients with grade-III ascites.
• Age 18 to 80 years.
• Willing to consent for clinical trial.

You may not qualify if:

• Acute liver failure.
• Impaired consciousness.
• Patients with following concomitant diseases,
• Severe cardiac diseases, respiratory diseases, and Renal impairment, (S. Creatinine \>1.5 mg/dl).
• Hyponatremia.
• Advanced HCC (\>3 nodule, portal vein thrombosis)
• Hepatic encephalopathy,
• Sepsis,
• Recent bleeding, e.g., GIT hemorrhage within 7 days before study.
• Pregnancy.
• Unable or not willing to consent for clinical trial.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Department of Hepatology, Bangabandhu Sheikh Mujib Medical University. Dhaka, Bangladesh.

Dhaka, Shahbag, 1000, Bangladesh

Location

Related Publications (11)

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  PMID: 37237088 BACKGROUND

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• Lijnen P, Fagard R, Staessen J, Amery A. Effect of chronic diuretic treatment on the plasma renin-angiotensin-aldosterone system in essential hypertension. Br J Clin Pharmacol. 1981 Sep;12(3):387-92. doi: 10.1111/j.1365-2125.1981.tb01231.x.

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• Kulkarni AV, Kumar P, Sharma M, Sowmya TR, Talukdar R, Rao PN, Reddy DN. Pathophysiology and Prevention of Paracentesis-induced Circulatory Dysfunction: A Concise Review. J Clin Transl Hepatol. 2020 Mar 28;8(1):42-48. doi: 10.14218/JCTH.2019.00048. Epub 2020 Mar 26.

  PMID: 32274344 BACKGROUND

• Gines P, Tito L, Arroyo V, Planas R, Panes J, Viver J, Torres M, Humbert P, Rimola A, Llach J, et al. Randomized comparative study of therapeutic paracentesis with and without intravenous albumin in cirrhosis. Gastroenterology. 1988 Jun;94(6):1493-502. doi: 10.1016/0016-5085(88)90691-9.

  PMID: 3360270 BACKGROUND

• Gines A, Fernandez-Esparrach G, Monescillo A, Vila C, Domenech E, Abecasis R, Angeli P, Ruiz-Del-Arbol L, Planas R, Sola R, Gines P, Terg R, Inglada L, Vaque P, Salerno F, Vargas V, Clemente G, Quer JC, Jimenez W, Arroyo V, Rodes J. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996 Oct;111(4):1002-10. doi: 10.1016/s0016-5085(96)70068-9.

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• Carvalho JR, Verdelho Machado M. New Insights About Albumin and Liver Disease. Ann Hepatol. 2018 July - August ,;17(4):547-560. doi: 10.5604/01.3001.0012.0916.

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• Bai Z, Wang L, Wang R, Zou M, Mendez-Sanchez N, Romeiro FG, Cheng G, Qi X. Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. Hepatol Int. 2022 Dec;16(6):1468-1483. doi: 10.1007/s12072-022-10374-z. Epub 2022 Sep 1.

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• Alessandria C, Elia C, Mezzabotta L, Risso A, Andrealli A, Spandre M, Morgando A, Marzano A, Rizzetto M. Prevention of paracentesis-induced circulatory dysfunction in cirrhosis: standard vs half albumin doses. A prospective, randomized, unblinded pilot study. Dig Liver Dis. 2011 Nov;43(11):881-6. doi: 10.1016/j.dld.2011.06.001. Epub 2011 Jul 8.

  PMID: 21741331 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thesis student of Doctor of Medicine (MD)

Model Details: Low dose albumin infusion compared with standard dose albumin infusion after large volume paracentesis in decompensated cirrhosis of liver. Intervention group: Low dose albumin. Control group: Standard dose albumin. Randomization was made by using the Random Allocation Software, version 1, 2022.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 24, 2025
• Study Start: February 2, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-02

Locations

BA (1)