跳至主要内容
临床试验/NCT02811406
NCT02811406Unknown不适用

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

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Rates of hypotension

研究概览

简要总结

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.

详细描述

General Introduction:

Therapeutic paracentesis is the first line of treatment for patients with symptomatic malignant ascites. The practice of intravenous albumin infusion during abdominal paracentesis comes from evidence in patients with liver cirrhosis. A meta-analysis of seventeen randomised trials evaluating patients receiving albumin versus alternative treatment during large volume paracentesis found that albumin reduced the incidence of post-paracentesis circulatory dysfunction, hyponatraemia and mortality (Bernardi M, 2012). The mechanisms of ascites in patients with cirrhosis are driven by portal hypertension. Portal hypertension brings about systemic vasodilation and hyperdynamic circulation that eventually contribute to functional and biochemical changes leading to ascites (Gines. P, 1997).

In contrast, cause of ascites in patients with malignancies is usually multi-factorial. It occurs commonly in several tumours including malignancies of ovary, breast, colon, lung, pancreas and liver. In each of these cancer types, the mechanisms leading to malignancy-related ascites may be different. Peritoneal carcinomatosis is a major cause of malignancy-related ascites. Other causes include massive liver metastasis causing portal hypertension, chronic hypoalbuminaemia, hepatocellular carcinoma, chylous ascites from lymphoma and Budd-Chiari syndrome due to occlusion of hepatic veins (Runyon BA, 1988).

In patients with cancer, aside from those who develop ascites as a result of portal hypertension, the benefit of intravenous albumin infusion with large volume paracentesis is uncertain, if at all present. Locally, the current clinical practice is for infusion of intravenous albumin during abdominal paracentesis in patients with malignancy-related ascites regardless of cause. The drawbacks of such an approach include exposing patients to risk of anaphylaxis and increased financial costs (50 ml of 20% Albumin costs $42).

Granted that the potential harms of albumin infusion are rare, the burden of proof to show that an intervention works is held by those who introduce it. To date, there have been no studies specifically examining the role of intravenous albumin infusion in this population. In the setting of advanced cancer where life expectancy is limited, the most clinically relevant benefit of albumin infusion would be to reduce the rates of post-paracentesis circulatory dysfunction. Through a pilot study, we hope to evaluate the effectiveness of IV albumin in reducing rates of hypotension, thereby guiding clinical practice in this area.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Receives IV albumin infusion

Experimental

IV albumin 20% 50 mL for every 1L of ascitic fluid drained

干预措施: Receives IV albumin infusion (Procedure)

Do not receive IV albumin infusion

Placebo Comparator

No IV albumin infusion

干预措施: Do not receive IV albumin infusion (Biological)

结局指标

主要结局

Rates of hypotension

时间窗: For 48 hours since start of drainage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验