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

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ClinicalTrials.gov Identifier: NCT02811406
Recruitment Status : Unknown
Verified June 2016 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.


Condition or disease Intervention/treatment Phase
Ascites Hypotension Procedure: Receives IV albumin infusion Biological: Do not receive IV albumin infusion Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of Intravenous Albumin Replacement During Abdominal Paracentesis in Patients With Malignancy Related Ascites
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Receives IV albumin infusion
IV albumin 20% 50 mL for every 1L of ascitic fluid drained
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.


Placebo Comparator: Do not receive IV albumin infusion
No IV albumin infusion
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.





Primary Outcome Measures :
  1. Rates of hypotension [ Time Frame: For 48 hours since start of drainage ]


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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811406


Contacts
Contact: Soo Chin Lee (65) 6779 5555 soo_chin_lee@nuhs.edu.sg
Contact: Gloria Hui Jia Chan (65) 6779 5555 gloria_chan@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 164119
Contact: Soo Chin Lee    (65) 6779 5555    soo_chin_lee@nuhs.edu.sg   
Contact: Gloria Hui Jia Chan    (65) 6779 5555    gloria_chan@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Soo Chin Lee National University Hospital, Singapore

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02811406     History of Changes
Other Study ID Numbers: MC01/02/16
2016/00326 ( Other Identifier: NHG DSRB )
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypotension
Ascites
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes