Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
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ClinicalTrials.gov Identifier: NCT00511394 |
Recruitment Status :
Suspended
First Posted : August 3, 2007
Last Update Posted : October 15, 2008
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Condition or disease | Intervention/treatment | Phase |
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Cirrhosis Ascites | Drug: 20% Human Albumin Drug: Normal Saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Diagnostic |
Official Title: | Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial |
Study Start Date : | May 2007 |
Estimated Primary Completion Date : | December 2008 |
Estimated Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: I
Infusion of 100 mL of 20% Albumin
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Drug: 20% Human Albumin
Infusion of 100 mL of 20% Albumin over 3 hours |
Placebo Comparator: II
100 mL Normal Saline
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Drug: Normal Saline
Infusion of 100 mL of Normal Saline |
- Immediate change in mean arterial pressure, cardiac output, systemic vascular resistance, pulmonary capillary wedge pressure, pulmonary vascular resistance and HVPG on infusion of 100 ml of 20% albumin or normal saline in decompensated cirrhotics [ Time Frame: Immediately after 3 hours of infusion ]
- Adverse effects to the drug (albumin or normal saline) [ Time Frame: During or immediately after infusion ]

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Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with cirrhosis with ascites admitted to the GE ward
- They require intravenous albumin therapy, for the management of their cirrhotic ascites
- Their serum albumin <2.8 g/dL
Exclusion Criteria:
- Cirrhotics without ascites
- Acute on chronic liver failure
- Serum bilirubin >3 mg/dL
- Hepatorenal syndrome
- Patients suffering from heart disease, history of allergy to albumin, pregnant women, hypertension, chronic nephritis
- Lack of informed written consent

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): NCT00511394
India | |
Department of Gastroenterology, G B Pant Hospital | |
New Delhi, Delhi, India, 110002 |
Principal Investigator: | Shiv K Sarin, MD, DM | Govind Ballabh Pant Hospital |
Responsible Party: | Dr S K Sarin, G B Pant Hospital |
ClinicalTrials.gov Identifier: | NCT00511394 |
Other Study ID Numbers: |
2007-PHT-01 |
First Posted: | August 3, 2007 Key Record Dates |
Last Update Posted: | October 15, 2008 |
Last Verified: | October 2008 |
Decompensated Cirrhosis with Ascites |
Liver Cirrhosis Fibrosis Ascites |
Pathologic Processes Liver Diseases Digestive System Diseases |