The Role of Intravenous Albumin Replacement During Abdominal Paracentesis in Patients With Malignancy Related Ascites
2 other identifiers
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 23, 2016
June 1, 2016
1 year
June 21, 2016
June 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Rates of hypotension
For 48 hours since start of drainage
Study Arms (2)
Receives IV albumin infusion
EXPERIMENTALIV albumin 20% 50 mL for every 1L of ascitic fluid drained
Do not receive IV albumin infusion
PLACEBO COMPARATORNo IV albumin infusion
Interventions
IV albumin 20% 50 mL for every 1L of ascitic fluid drained. Blood pressure and heart rate are recorded every four hours in both groups in the first 48 hours. If hypotension occurs (defined as fall in systolic blood pressure of \> 20 mmHg from baseline) during drainage, drain is clamped and the patient will be clinically evaluated for cause of hypotension. If no other causes of hypotension are found and patient remains asymptomatic, repeat blood pressure measurement in 30 minutes. If blood pressure maintains \> 90/50 mmHg after 30 minutes and patient is asymptomatic, continue drainage and patient stays in the study. If patient remains hypotensive (BP \< 90/50) or develops symptomatic hypotension, then the patient will be taken off study and the hypotension managed as clinically indicated.
No IV albumin infusion. Blood pressure and heart rate are recorded every four hours in both groups in the first 48 hours. If hypotension occurs (defined as fall in systolic blood pressure of \> 20 mmHg from baseline) during drainage, drain is clamped and the patient will be clinically evaluated for cause of hypotension. If no other causes of hypotension are found and patient remains asymptomatic, repeat blood pressure measurement in 30 minutes. If blood pressure maintains \> 90/50 mmHg after 30 minutes and patient is asymptomatic, continue drainage and patient stays in the study. If patient remains hypotensive (BP \< 90/50) or develops symptomatic hypotension, then the patient will be taken off study and the hypotension managed as clinically indicated.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, Singapore, 164119, Singapore
Related Publications (2)
Bernardi 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: 22095893BACKGROUNDGrabau 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: 15368454BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soo Chin Lee
National University Hospital, Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 23, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
June 23, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share