Decompensated Cirrhosis and AscitesPhase 4NCT07917819
Low Dose Versus Standard Dose Albumin
A Phase 4 study testing Low dose Albumin and standard dose albumin in people with Decompensated Cirrhosis and Ascites, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
Background: Liver cirrhosis with ascites is a major health problem, and large-volume paracentesis (LVP) is commonly performed for management of tense or refractory ascites. However, LVP is associated with paracentesis-induced circulatory dysfunction (PICD), which can lead to renal impairment, hyponatremia, rapid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis and Ascites
- What is being tested?
- Low dose Albumin and standard dose albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBangladesh
- Study dates
- 19 Oct 2026to 30 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years) diagnosed with decompensated liver cirrhosis
- Patients with tense or refractory ascites requiring large-volume paracentesis (removal of ≥5 liters of ascitic fluid).
Who cannot join
- Patients with Sepsis
- Patients with hepatorenal syndrome (HRS) or baseline serum creatinine >1.5 mg/dL
- Patients with hepatic encephalopathy
- Patients receiving vasoconstrictor drugs (e.g., terlipressin, midodrine).
- Pregnant women.
- Severe Hyponatremia
- Recent GI bleeding (within last 7 days)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Department of Hepatology,Bangladesh Medical Univdersity
Dhaka
About this study
Official title: Low Dose Versus Standard Dose Albumin in Preventing Paracentesis Induced Circulatory Dysfunction Following Large Volume Paracentesis
Background:
Liver cirrhosis with ascites is a major health problem, and large-volume paracentesis (LVP) is commonly performed for management of tense or refractory ascites. However, LVP is associated with paracentesis-induced circulatory dysfunction (PICD), which can lead to renal impairment, hyponatremia, rapid recurrence of ascites, and increased mortality. Human albumin is the most effective plasma expander for prevention of PICD, but its high cost limits its use in resource-limited settings like Bangladesh.
Read more
Objective:
To compare the effectiveness of low-dose albumin (4 g/L) versus standard-dose albumin (6 g/L) in preventing PICD following large-volume paracentesis in patients with liver cirrhosis.
Methods:
This prospective randomized controlled clinical trial will be conducted in the Department of Hepatology, Bangladesh Medical University (BMU). Adult cirrhotic patients with tense or refractory ascites requiring LVP will be enrolled. Eligible participants will be randomly allocated into two groups: low-dose albumin (4 g/L) and standard-dose albumin (6 g/L). Baseline clinical and laboratory parameters, including plasma renin activity (PRA), will be recorded on day 0. After LVP, albumin will be administered according to group allocation. Patients will be followed up on Day 6 and Day 14 after LVP. Plasma renin activity will be reassessed on Day 6 for diagnosis of PICD, while renal and liver function tests will be reassessed on Day 14.. Data will be analyzed using SPSS, and p-value <0.05 will be considered statistically significant.
Conclusion:
The study is expected to determine whether low-dose albumin is as effective as standard-dose albumin in preventing PICD. A positive result may support the use of a cost-effective regimen, improving accessibility and clinical outcomes in cirrhotic patients undergoing LVP.
Read the detailed description
Introduction Liver cirrhosis represents the terminal stage of chronic liver injury, characterized by fibrosis, distortion of hepatic architecture, and formation of regenerative nodules. It remains a major global health burden with significant mortality, particularly after the onset of decompensation.
Ascites develops as a consequence of portal hypertension and systemic circulatory alterations. It indicates advanced disease, especially when it becomes refractory to standard therapy. Refractory ascites is associated with reduced survival and often necessitates interventional management.
Large-volume paracentesis (LVP) is an established and commonly used therapeutic procedure for the management of tense or refractory ascites. It offers rapid symptomatic relief and is considered more effective and safer compared to alternative approaches such as transjugular intrahepatic portosystemic shunt in many clinical settings.
The procedure is particularly indicated in patients with tense ascites causing discomfort or respiratory compromise, as well as in those who fail to respond adequately to sodium restriction and diuretic therapy.
LVP is associated with a significant complication known as paracentesis-induced circulatory dysfunction (PICD). This condition typically occurs after removal of large volumes of ascitic fluid, especially more than 5-6 liters.
Paracentesis-induced circulatory dysfunction (PICD) is a condition marked by significant activation of the renin-angiotensin system, occurring as a result of worsening arteriolar vasodilation that is already present in cirrhotic patients. It can develop in up to 80% of patients who do not receive plasma expanders following large-volume paracentesis; however, the use of plasma volume expansion markedly decreases its incidence.
To prevent PICD, plasma volume expanders are routinely administered following LVP.Various expanders such as dextran, polygeline, and saline have been used; however, their efficacy in preventing PICD is variable. Among these, human albumin has emerged as the most widely used and effective agent.
Albumin is a key plasma protein synthesized by the liver, contributing significantly to oncotic pressure. In addition to its volume-expanding properties, albumin exhibits anti-inflammatory, antioxidant, and immunomodulatory effects, which may influence outcomes in patients with cirrhosis.
Hypoalbuminemia is common in cirrhotic patients due to decreased synthesis, dilution, and loss into ascitic fluid, further supporting the rationale for exogenous albumin administration.
The role of albumin in preventing PICD is well established. It acts by expanding plasma volume, improving circulatory function, and reducing activation of vasoconstrictor systems. Clinical studies have demonstrated that albumin significantly lowers the incidence of PICD and related complications, including renal dysfunction and hyponatremia, when compared with other plasma expanders.
However, the use of albumin is limited by its relatively high cost, particularly in resource-constrained settings. This has prompted investigation into lower dosing regimens that may provide similar efficacy while reducing financial burden. Conventional dosing recommendations often suggest 6-8 g of albumin per liter of ascitic fluid removed, but emerging evidence indicates that reduced doses, such as 4 g/L, may be effective and more economical.
In addition to circulatory dysfunction, patients undergoing large-volume paracentesis remain at risk of subsequent renal impairment, worsening liver function. These clinically relevant outcomes contribute to morbidity, repeated hospital visits, and poorer prognosis in patients with decompensated cirrhosis.
Given the clinical importance of preventing PICD and the economic implications of albumin therapy, there is a need to evaluate whether lower doses of albumin are as effective as standard doses. This study aims to compare reduced-dose albumin (4 g/L) with standard-dose albumin (6g/L) in preventing PICD following large-volume paracentesis, with the goal of optimizing both clinical outcomes and cost-effectiveness.
General Objective
To evaluate the effectiveness of low-dose albumin (4 g/L) compared to standard-dose albumin (6g/L) in preventing paracentesis-induced circulatory dysfunction (PICD) in patients with liver cirrhosis undergoing large-volume paracentesis.
Specific Objectives
- To compare renal function (serum creatinine) before and following large-volume paracentesis in both groups.
- To evaluate the occurrence of hyponatremia after paracentesis in patients receiving low-dose versus standard-dose albumin.
- To compare Plasma Renin Activity (PRA) in patients receiving low-dose versus standard-dose albumin.
- To compare the adverse effects in patients receiving low-dose versus standard-dose albumin.
- To compare the incidence of paracentesis-induced circulatory dysfunction between low-dose and standard-dose albumin groups
- Conditions
- Decompensated Cirrhosis and Ascites
- Being tested
- Low dose Albumin, standard dose albumin
- Keywords
- Low dose albumin, Paracentesis induced circulatory dysfunction, Decompensated Cirrhosis, Standard Dose
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose AlbuminDrug
Inj.Albumin (Human) 20% 4gm/L for each litre of ascitic fluid removed
standard dose albuminDrug
Inj.Albumin (Human) 20% 6gm/L for each litre of ascitic fluid removed
| Study group | Role | What they receive |
|---|---|---|
| Standard dose albumin | Active comparator | 6gm/L Albumin for each litre of ascitic fluid removed Receives: Drug: standard dose albumin |
| Low dose albumin | Experimental | 4gm/L Albumin for each litre of ascitic fluid removed Receives: Drug: Low dose Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Paracentesis-Induced Circulatory Dysfunction (PICD) in patients of both groups,6th day following paracentesis
Incidence of Paracentesis-Induced Circulatory Dysfunction (PICD) in patients of both groups,6th day following paracentesis
Measured: 6 days
Secondary outcomes (4)
Changes in serum creatinine from baseline to day 6 following large volume paracentesis
Changes in serum creatinine from baseline to day 6 following large volume paracentesis in both treatment groups,expressed in mg/dL
Measured: Baseline to 6 days
Incidence of Hyponatremia following Large volume paracentesis
Incidence of Hyponatremia expressed in mmol/L within 6 days following Large volume paracentesis in each treatment group
Measured: within 6 days following paracentesis
Incidence of adverse events related to Albumin administration
Percentage of patients experiencing at least one adverse event related to albumin administration during 6 day observation period in each treatment group
Measured: From the day of albumin infusion following large volume paracentesis (day 0) through day 6 following the procedure(up to 6 days)
Length of hospital stay
Duration of hospitalization measured in days, calculated from the date of hospital admission to the date of discharge, and compared between the treatment groups
Measured: From hospital admission to discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start19 Oct 2026 (estimated)
- Primary completion4 Aug 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decompensated Cirrhosis and AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Shyeam Hasan, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917819
- Sponsor's protocol ID
- PR-6313
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alessandria, C., Elia, C., Mezzabotta, L., Risso, A., Andrealli, A. and Spandre, M., 2011. Prevention of paracentesis-induced circulatory dysfunction in cirrhosis: standard vs half albumin doses. Digestive and Liver Disease, 43(11), pp.881-886. Alsebaey, A., Rewisha, E. and Waked, I., 2020. High efficacy of low-dose albumin infusion in the prevention of paracentesis-induced circulatory dysfunction. Egyptian Liver Journal, 10(1), p.39. Angeli, P., Ginès, P., Wong, F., Bernardi, M., Boyer, T.D., Gerbes, A.,2015. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Journal of Hepatology, 62(4), pp.968-974. Bai, Z., Wang, L., Wang, R., Zou, M., Méndez-Sánchez, N. and Romeiro, F.G., 2022. Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. Hepatology International, 16(6), pp.1468-1483. Bernardi, M., Caraceni, P., Navickis, R.J. and Wilkes, M.M., 2012. Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials. Hepatology, 55(4), pp.1172-1181. Bot, K.K.I.M., Heus, R., Drenth, J.P.H. and Lantinga, M.A., 2026. Low-dose vs. standard care IV human albumin during large-volume paracentesis in patients with liver cirrhosis: a systematic review. Liver International, 46, e70621. https://doi.org/10.1111/liv.70621 Carvalho, J.R. and Machado, M.V., 2018. New insights about albumin and liver disease. Annals of Hepatology, 17(4), pp.547-560. European Association for the Study of the Liver (EASL), 2018. EASL clinical practice guidelines for the management of patients with decompensated cirrhosis. Journal of Hepatology, 69(2), pp.406-460. Forner, A., Reig, M. and Bruix, J., 2018. Hepatocellular carcinoma. The Lancet, 391(10127), pp.1301-1314. Ginès, A., Fernández-Esparrach, G., Monescillo, A., Vila, C., Domenech, E., Abecasis, R. and others, 1996. Randomized trial compar
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Versus Standard Dose Albumin in Preventing Paracentesis Induced Circulatory Dysfunction Following Large Volume Paracentesis
- ClinicalTrials.gov ID
- NCT07917819
- Acronym / sponsor ID
- PR-6313
- Conditions
- Decompensated Cirrhosis and Ascites
- Keywords
- Low dose albumin, Paracentesis induced circulatory dysfunction, Decompensated Cirrhosis, Standard Dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 4 Aug 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Liver cirrhosis with ascites is a major health problem, and large-volume paracentesis (LVP) is commonly performed for management of tense or refractory ascites. However, LVP is associated with paracentesis-induced circulatory dysfunction (PICD), which can lead to renal impairment, hyponatremia, rapid recurrence of ascites, and increased mortality. Human albumin is the most effective plasma expander for prevention of PICD, but its high cost limits its use in resource-limited settings like Bangladesh.
Objective:
To compare the effectiveness of low-dose albumin (4 g/L) versus standard-dose albumin (6 g/L) in preventing PICD following large-volume paracentesis in patients with liver cirrhosis.
Methods:
This prospective randomized controlled clinical trial will be conducted in the Department of Hepatology, Bangladesh Medical University (BMU). Adult cirrhotic patients with tense or refractory ascites requiring LVP will be enrolled. Eligible participants will be randomly allocated into two groups: low-dose albumin (4 g/L) and standard-dose albumin (6 g/L). Baseline clinical and laboratory parameters, including plasma renin activity (PRA), will be recorded on day 0. After LVP, albumin will be administered according to group allocation. Patients will be followed up on Day 6 and Day 14 after LVP. Plasma renin activity will be reassessed on Day 6 for diagnosis of PICD, while renal and liver function tests will be reassessed on Day 14.. Data will be analyzed using SPSS, and p-value <0.05 will be considered statistically significant.
Conclusion:
The study is expected to determine whether low-dose albumin is as effective as standard-dose albumin in preventing PICD. A positive result may support the use of a cost-effective regimen, improving accessibility and clinical outcomes in cirrhotic patients undergoing LVP.
Detailed description
Introduction Liver cirrhosis represents the terminal stage of chronic liver injury, characterized by fibrosis, distortion of hepatic architecture, and formation of regenerative nodules. It remains a major global health burden with significant mortality, particularly after the onset of decompensation.
Ascites develops as a consequence of portal hypertension and systemic circulatory alterations. It indicates advanced disease, especially when it becomes refractory to standard therapy. Refractory ascites is associated with reduced survival and often necessitates interventional management.
Large-volume paracentesis (LVP) is an established and commonly used therapeutic procedure for the management of tense or refractory ascites. It offers rapid symptomatic relief and is considered more effective and safer compared to alternative approaches such as transjugular intrahepatic portosystemic shunt in many clinical settings.
The procedure is particularly indicated in patients with tense ascites causing discomfort or respiratory compromise, as well as in those who fail to respond adequately to sodium restriction and diuretic therapy.
LVP is associated with a significant complication known as paracentesis-induced circulatory dysfunction (PICD). This condition typically occurs after removal of large volumes of ascitic fluid, especially more than 5-6 liters.
Paracentesis-induced circulatory dysfunction (PICD) is a condition marked by significant activation of the renin-angiotensin system, occurring as a result of worsening arteriolar vasodilation that is already present in cirrhotic patients. It can develop in up to 80% of patients who do not receive plasma expanders following large-volume paracentesis; however, the use of plasma volume expansion markedly decreases its incidence.
To prevent PICD, plasma volume expanders are routinely administered following LVP.Various expanders such as dextran, polygeline, and saline have been used; however, their efficacy in preventing PICD is variable. Among these, human albumin has emerged as the most widely used and effective agent.
Albumin is a key plasma protein synthesized by the liver, contributing significantly to oncotic pressure. In addition to its volume-expanding properties, albumin exhibits anti-inflammatory, antioxidant, and immunomodulatory effects, which may influence outcomes in patients with cirrhosis.
Hypoalbuminemia is common in cirrhotic patients due to decreased synthesis, dilution, and loss into ascitic fluid, further supporting the rationale for exogenous albumin administration.
The role of albumin in preventing PICD is well established. It acts by expanding plasma volume, improving circulatory function, and reducing activation of vasoconstrictor systems. Clinical studies have demonstrated that albumin significantly lowers the incidence of PICD and related complications, including renal dysfunction and hyponatremia, when compared with other plasma expanders.
However, the use of albumin is limited by its relatively high cost, particularly in resource-constrained settings. This has prompted investigation into lower dosing regimens that may provide similar efficacy while reducing financial burden. Conventional dosing recommendations often suggest 6-8 g of albumin per liter of ascitic fluid removed, but emerging evidence indicates that reduced doses, such as 4 g/L, may be effective and more economical.
In addition to circulatory dysfunction, patients undergoing large-volume paracentesis remain at risk of subsequent renal impairment, worsening liver function. These clinically relevant outcomes contribute to morbidity, repeated hospital visits, and poorer prognosis in patients with decompensated cirrhosis.
Given the clinical importance of preventing PICD and the economic implications of albumin therapy, there is a need to evaluate whether lower doses of albumin are as effective as standard doses. This study aims to compare reduced-dose albumin (4 g/L) with standard-dose albumin (6g/L) in preventing PICD following large-volume paracentesis, with the goal of optimizing both clinical outcomes and cost-effectiveness.
General Objective
To evaluate the effectiveness of low-dose albumin (4 g/L) compared to standard-dose albumin (6g/L) in preventing paracentesis-induced circulatory dysfunction (PICD) in patients with liver cirrhosis undergoing large-volume paracentesis.
Specific Objectives
- To compare renal function (serum creatinine) before and following large-volume paracentesis in both groups.
- To evaluate the occurrence of hyponatremia after paracentesis in patients receiving low-dose versus standard-dose albumin.
- To compare Plasma Renin Activity (PRA) in patients receiving low-dose versus standard-dose albumin.
- To compare the adverse effects in patients receiving low-dose versus standard-dose albumin.
- To compare the incidence of paracentesis-induced circulatory dysfunction between low-dose and standard-dose albumin groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose albumin | Active comparator | Drug: standard dose albumin6gm/L Albumin for each litre of ascitic fluid removed |
| Low dose albumin | Experimental | Drug: Low dose Albumin4gm/L Albumin for each litre of ascitic fluid removed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years) diagnosed with decompensated liver cirrhosis
- Patients with tense or refractory ascites requiring large-volume paracentesis (removal of ≥5 liters of ascitic fluid).
Key exclusion criteria (7 listed)
- Patients with Sepsis
- Patients with hepatorenal syndrome (HRS) or baseline serum creatinine >1.5 mg/dL
- Patients with hepatic encephalopathy
- Patients receiving vasoconstrictor drugs (e.g., terlipressin, midodrine).
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose AlbuminInj.Albumin (Human) 20% 4gm/L for each litre of ascitic fluid removed | Drug | Low dose albumin |
| standard dose albuminInj.Albumin (Human) 20% 6gm/L for each litre of ascitic fluid removed | Drug | Standard dose albumin |
Primary outcome
Incidence of Paracentesis-Induced Circulatory Dysfunction (PICD) in patients of both groups,6th day following paracentesis
Time frame: 6 days
Incidence of Paracentesis-Induced Circulatory Dysfunction (PICD) in patients of both groups,6th day following paracentesis
4 secondary outcomes
Changes in serum creatinine from baseline to day 6 following large volume paracentesis
Time frame: Baseline to 6 days
Incidence of Hyponatremia following Large volume paracentesis
Time frame: within 6 days following paracentesis
Incidence of adverse events related to Albumin administration
Time frame: From the day of albumin infusion following large volume paracentesis (day 0) through day 6 following the procedure(up to 6 days)
Length of hospital stay
Time frame: From hospital admission to discharge, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- BackgroundAlessandria, C., Elia, C., Mezzabotta, L., Risso, A., Andrealli, A. and Spandre, M., 2011. Prevention of paracentesis-induced circulatory dysfunction in cirrhosis: standard vs half albumin doses. Digestive and Liver Disease, 43(11), pp.881-886. Alsebaey, A., Rewisha, E. and Waked, I., 2020. High efficacy of low-dose albumin infusion in the prevention of paracentesis-induced circulatory dysfunction. Egyptian Liver Journal, 10(1), p.39. Angeli, P., Ginès, P., Wong, F., Bernardi, M., Boyer, T.D., Gerbes, A.,2015. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Journal of Hepatology, 62(4), pp.968-974. Bai, Z., Wang, L., Wang, R., Zou, M., Méndez-Sánchez, N. and Romeiro, F.G., 2022. Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. Hepatology International, 16(6), pp.1468-1483. Bernardi, M., Caraceni, P., Navickis, R.J. and Wilkes, M.M., 2012. Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials. Hepatology, 55(4), pp.1172-1181. Bot, K.K.I.M., Heus, R., Drenth, J.P.H. and Lantinga, M.A., 2026. Low-dose vs. standard care IV human albumin during large-volume paracentesis in patients with liver cirrhosis: a systematic review. Liver International, 46, e70621. https://doi.org/10.1111/liv.70621 Carvalho, J.R. and Machado, M.V., 2018. New insights about albumin and liver disease. Annals of Hepatology, 17(4), pp.547-560. European Association for the Study of the Liver (EASL), 2018. EASL clinical practice guidelines for the management of patients with decompensated cirrhosis. Journal of Hepatology, 69(2), pp.406-460. Forner, A., Reig, M. and Bruix, J., 2018. Hepatocellular carcinoma. The Lancet, 391(10127), pp.1301-1314. Ginès, A., Fernández-Esparrach, G., Monescillo, A., Vila, C., Domenech, E., Abecasis, R. and others, 1996. Randomized trial compar
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose Albumin and standard dose albumin in people with Decompensated Cirrhosis and Ascites, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Paracentesis-Induced Circulatory Dysfunction (PICD) in patients of both groups,6th day following paracentesis (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07917819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.