The Role of Intravenous Albumin Replacement During Abdominal Paracentesis in Patients With Malignancy Related Ascites

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.

Conditions

• Ascites
• Hypotension

Interventions

PROCEDURE

Receives IV albumin infusion

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.

BIOLOGICAL

Do not receive IV albumin infusion

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.

Sponsors & Collaborators

• National University Hospital, Singapore

  lead OTHER

Principal Investigators

• Soo Chin Lee · National University Hospital, Singapore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2017-06-30

Completion

2017-12-31

Countries

• Singapore

Study Locations