Clinical trial · Interventional
The Role of Intravenous Albumin Replacement During Abdominal Paracentesis in Patients With Malignancy Related Ascites
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aims: To compare the rates of hypotension in patients with malignancy-related ascites undergoing abdominal paracentesis with and without prophylactic intravenous albumin infusion Methodology: Patients with symptomatic ascites secondary to underlying malignancy admitted to medical oncology inpatient service who require abdominal paracentesis will be enrolled. Patients with known portal hypertension based on SAAG (\>11.1 mmol/L) will be excluded. Eligible patients are randomized 1:1 to two groups. During drainage of ascites fluid, one group will receive intravenous albumin infusion (50 ml/Litre of ascitic fluid drained), whereas the other group will not receive intravenous albumin infusion. Baseline parameters along with routine 4 hourly monitoring of blood pressure will be done. Episodes of hypotension (fall in SBP \> 20 mmHg) will be compared between these two groups and significance tested using the chi-square test. Clinical significance: Ascites often occurs in the setting of advanced malignancy and drainage of ascites has been proven to provide symptomatic relief in this patient population with relatively short life expectancy. The use of intravenous albumin infusion is loosely extrapolated from studies in patients with liver cirrhosis undergoing abdominal paracentesis. To date, there have been no standard guidelines to guide practice and no studies looking at the use of intravenous albumin in this population. As the mechanisms of ascites are different in different malignancies, the indication of intravenous albumin is uncertain and perhaps unnecessary in this setting. We hope to understand more about the rates of hypotension during abdominal paracentesis in this population and to generate systematic data to guide clinical practice in this area.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ascites | — | UNRESOLVED | — |
| Hypotension | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Do not receive IV albumin infusion | Biological | — | UNRESOLVED |
| Receives IV albumin infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Receives IV albumin infusion
- description
- IV albumin 20% 50 mL for every 1L of ascitic fluid drained
- interventionNames
- Procedure: Receives IV albumin infusion
- type
- PLACEBO_COMPARATOR
- label
- Do not receive IV albumin infusion
- description
- No IV albumin infusion
- interventionNames
- Biological: Do not receive IV albumin infusion
Primary outcomes (1)
- measure
- Rates of hypotension
- timeFrame
- For 48 hours since start of drainage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age more than 21 years old * Inpatients admitted to medical oncology service with symptomatic ascites and who are scheduled for abdominal paracentesis * Known underlying malignancy * Blood pressure before abdominal paracentesis more than 90/50 mmHg Exclusion Criteria: * Patients with known portal hypertension, defined by serum albumin: ascites gradient (SAAG) more than 11.1 mmol/L, based on previous results in last 1 year * Patients with a known history of hypotension when getting paracentesis * Pregnant women
References
Publications (2)
- BACKGROUNDBernardi M, Caraceni P, Navickis RJ, Wilkes MM. Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials. Hepatology. 2012 Apr;55(4):1172-81. doi: 10.1002/hep.24786. PMID 22095893
- BACKGROUNDGrabau CM, Crago SF, Hoff LK, Simon JA, Melton CA, Ott BJ, Kamath PS. Performance standards for therapeutic abdominal paracentesis. Hepatology. 2004 Aug;40(2):484-8. doi: 10.1002/hep.20317. PMID 15368454