CirrhosisNCT00511394
Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
A study testing 20% Human Albumin and Normal Saline in people with Cirrhosis and Ascites, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial summary
Cirrhosis is frequently complicated by derangement of body fluid homeostasis resulting in accumulation of large amounts of extracellular fluid in the peritoneal cavity (ascites) and interstitial tissue (edema). Studies showed that patients with cirrhosis and ascites have marked circulatory dysfunction. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- What is being tested?
- 20% Human Albumin and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIndia
- Study dates
- May 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Gastroenterology, G B Pant Hospital
New Delhi, National Capital Territory of Delhi, 110002
About this study
Official title: Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial
Cirrhosis is frequently complicated by derangement of body fluid homeostasis resulting in accumulation of large amounts of extracellular fluid in the peritoneal cavity (ascites) and interstitial tissue (edema). Studies showed that patients with cirrhosis and ascites have marked circulatory dysfunction. Albumin infusions have been used for many years in the management of patients with cirrhosis and ascites in an attempt to reduce the formation of ascites and/or improve circulatory and renal function. While some of these indications for albumin infusions are supported by the results of randomised studies, others are based on clinical experience and have not been proved in prospective investigations. Therefore, the use of albumin infusions in patients with cirrhosis is controversial. Recently, this debate has been fostered by the high cost and limited availability of albumin and the results of a meta-analysis showing that albumin administration may increase mortality in critically ill patients. In cirrhotics, there is a significant improvement in the low effective arterial blood volume, which may be important in the prevention of circulatory dysfunction and in preventing renal impairment. However, in an already fluid overload state such as that of cirrhosis, albumin infusion predisposes the individual to develop pulmonary edema. There is no study demonstrating acute effect of albumin infusion on hemodynamic parameters, in cirrhotic patients. Neither is there is data concerning comparison between albumin and normal saline. It is postulated that it may increase portal pressure thereby increasing the risk of variceal bleed. This study hypothesizes that albumin infusion might lead to alteration in portal and pulmonary hemodynamics in decompensated cirrhotic patients. Included patients of cirrhosis with ascites (based on inclusion and exclusion criteria) will undergo baseline investigations (systemic hemodynamics, pulmonary hemodynamics, portal hemodynamics). They will be randomized into two groups, each of 8. One group will receive infusion of 100 ml 20% albumin over 3 hours, and the other will receive infusion of 100 ml normal saline over 3 hours. Repeat hemodynamic studies will be performed after the infusion finishes. All results will be expressed as mean ± SD or frequency (%). Comparisons will be performed by the Student's t test or with the Wilcoxon's test
- Being tested
- 20% Human Albumin, Normal Saline
- Keywords
- Decompensated Cirrhosis with Ascites
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% Human AlbuminDrug
Infusion of 100 mL of 20% Albumin over 3 hours
Normal SalineDrug
Infusion of 100 mL of Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Infusion of 100 mL of 20% Albumin Receives: Drug: 20% Human Albumin |
| II | Placebo comparator | 100 mL Normal Saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after 3 hours of infusion
Secondary outcomes (1)
Adverse effects to the drug (albumin or normal saline)
Measured: During or immediately after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Investigators
- Shiv K Sarin, MD, DM, Principal investigator, Govind Ballabh Pant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511394
- Sponsor's protocol ID
- 2007-PHT-01
- Status last verified
- Oct 2008
- First submitted
- 2 Aug 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00511394
- Acronym / sponsor ID
- 2007-PHT-01
- Keywords
- Decompensated Cirrhosis with Ascites
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- May 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cirrhosis is frequently complicated by derangement of body fluid homeostasis resulting in accumulation of large amounts of extracellular fluid in the peritoneal cavity (ascites) and interstitial tissue (edema). Studies showed that patients with cirrhosis and ascites have marked circulatory dysfunction. Albumin infusions have been used for many years in the management of patients with cirrhosis and ascites in an attempt to reduce the formation of ascites and/or improve circulatory and renal function. While some of these indications for albumin infusions are supported by the results of randomised studies, others are based on clinical experience and have not been proved in prospective investigations. Therefore, the use of albumin infusions in patients with cirrhosis is controversial. Recently, this debate has been fostered by the high cost and limited availability of albumin and the results of a meta-analysis showing that albumin administration may increase mortality in critically ill patients. In cirrhotics, there is a significant improvement in the low effective arterial blood volume, which may be important in the prevention of circulatory dysfunction and in preventing renal impairment. However, in an already fluid overload state such as that of cirrhosis, albumin infusion predisposes the individual to develop pulmonary edema. There is no study demonstrating acute effect of albumin infusion on hemodynamic parameters, in cirrhotic patients. Neither is there is data concerning comparison between albumin and normal saline. It is postulated that it may increase portal pressure thereby increasing the risk of variceal bleed. This study hypothesizes that albumin infusion might lead to alteration in portal and pulmonary hemodynamics in decompensated cirrhotic patients. Included patients of cirrhosis with ascites (based on inclusion and exclusion criteria) will undergo baseline investigations (systemic hemodynamics, pulmonary hemodynamics, portal hemodynamics). They will be randomized into two groups, each of 8. One group will receive infusion of 100 ml 20% albumin over 3 hours, and the other will receive infusion of 100 ml normal saline over 3 hours. Repeat hemodynamic studies will be performed after the infusion finishes. All results will be expressed as mean ± SD or frequency (%). Comparisons will be performed by the Student's t test or with the Wilcoxon's test
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: 20% Human AlbuminInfusion of 100 mL of 20% Albumin |
| II | Placebo comparator | Drug: Normal Saline100 mL Normal Saline |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20% Human AlbuminInfusion of 100 mL of 20% Albumin over 3 hours | Drug | I |
| Normal SalineInfusion of 100 mL of Normal Saline | Drug | II |
Primary outcome
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
1 secondary outcome
Adverse effects to the drug (albumin or normal saline)
Time frame: During or immediately after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiv K Sarin, MD, DM principal investigator
Govind Ballabh Pant Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20% Human Albumin and Normal Saline in people with Cirrhosis and Ascites, run by Govind Ballabh Pant Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.