Liver CirrhosisNCT06026267
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
A study testing 20% High Dose Albumin, Standard Medical Treatment and 20% Reduced Dose Albumin in people with Liver Cirrhosis and Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined, which decreases the morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Spontaneous Bacterial Peritonitis
- What is being tested?
- 20% High Dose Albumin, Standard Medical Treatment and 20% Reduced Dose Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- 10 Oct 2023to 31 Dec 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18years
- Cirrhosis with SBP (community acquired /Health care associated/ nosocomial)
- High risk SBP : Patients with S Bil >4 mg/dL and/or s creat > 1 mg/dl at presentation
Who cannot join
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known CKD or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV infection
- GI bleed within 1 month before the study
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- Grade 3 to 4 hepatic encephalopathy
- Shock (MAP < 65)
- Serum creatinine level of > 3 mg/decilitre
- Presence of any potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment within one week before the diagnosis of SBP).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Saurav Paul, MD, 01146300000, saurav.paul79@gmail.com
About this study
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined, which decreases the morbidity and mortality. However the conventional dose recommended by the guidelines is usually not tolerated by the Indian population. Investigator propose that the low dose is as beneficial as the standard dose in patients with high risk SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk spontaneous bacterial peritonitis. If confirmed, these results could support a significant cost reduction in the management of ascites in cirrhotic patients and decrease the side effects of the volume overload in the patient of the cirrhosis.
Read the detailed description
Hypothesis Alternate Hypothesis: Low dose albumin is as effective as conventional dose albumin in cirrhosis with high risk SBP patients having AKI development or progression by day 4.
Aim:-To compare the efficacy and safety of low dose albumin with conventional dose albumin in AKI development or progression in patients with cirrhosis and high risk spontaneous bacterial peritonitis.
Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/ICU diagnosed with high risk SBP.
Study design: Randomized controlled trial Study period:1.5year Sample size: 300 (150 cases in each group) Assuming that the rate of AKI development in conventional dose albumin group - 10% and low dose albumin group 15%, Power- 80%, Alpha- 10% ONE SIDED, Non inferiority limit- 5, cases needed to enroll are 270, further assuming 10% dropout, investigator decided to enroll total 300 cases, randomly allocated with 150 cases in each arm by block randomization method with Block size of 10 Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.
STATISTICAL ANALYSIS:
Continuous variables- Mean +/- SD Categorical variables as percentages (%) or Frequencies Student t test will be applied in continuous data compared with two groups Survival analysis like Cox-Regression model and Kaplan-Meir plots will be plotted to find the possible factors responsible for mortality Besides these, Intent to treat (ITT) and Per Protocol (PP) will be done at the time of data analysis.
Adverse effects:
Patients receiving Albumin may experience Nausea, Vomiting, Fever with chills, dyspnea Wheezing, Volume overload, Anaphylactic reaction
Stopping rule of study:
Adverse reaction to drug Cardiopulmonary compromise
- Conditions
- Liver Cirrhosis, Spontaneous Bacterial Peritonitis
- Being tested
- 20% High Dose Albumin, Standard Medical Treatment, 20% Reduced Dose Albumin
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% High Dose AlbuminBiological
A]. Patients in the conventional albumin Arm will receive Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg bodyweight (Maximum 100g)on day 3 along with standard medical therapy.
Duration of albumin over 24 hours.
Standard Medical TreatmentOther
Standard Medical Treatment
20% Reduced Dose AlbuminBiological
B]. Patients in the low dose albumin Arm will receive Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy.
Duration of albumin over 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Arm+Standard Medical therapy | Active comparator | Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg body weight (Maximum 100g)on day 3 along with standard medical therapy. Receives: Biological: 20% High Dose Albumin; Other: Standard Medical Treatment |
| Reduced Dose Albumin+Standard Medical therapy | Experimental | Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy. Receives: Other: Standard Medical Treatment; Biological: 20% Reduced Dose Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients developing new AKI or having progression of AKI by day 4.
Measured: Day 4
Secondary outcomes (15)
Resolution of Spontaneous Bacterial Peritonitis by day 5
Resolution is defined as decrease in ascitic fluid PMN > 25% from baseline
Measured: Day 5
Change on Serum Ascites Albumin Gradient (SAAG) in both the groups.
Measured: Day 5
Change in cell count (PMN) in both groups.
Measured: Day 5
Changes in PRA levels from baseline to day 7
Measured: day 7
Changes in TNF-alpha levels from baseline to day 7
Measured: day 7
Changes in IL-6 levels from baseline to day 7
Measured: day 7
Changes in endotoxin levels from baseline to day 7
Measured: day 7
Changes in renal resistive index from baseline to day 7
Measured: day 7
Number of patients with development of complications in both groups
Measured: 90 days
Number of Participants with changes in ProBNP from baseline to day 4 or if shortness of breath occurs
Measured: Day 4
Number of Participants with changes in vWF-Ag from baseline to day 4
Measured: Day 4
Number of patients expired in both the groups
Measured: Day 7
Number of patients expired in both the groups
Measured: Day 28
Number of patients expired in both the groups
Measured: Day 90
Duration of hospital stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start10 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026267
- Sponsor's protocol ID
- ILBS-Cirrhosis-59
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT06026267
- Acronym / sponsor ID
- ILBS-Cirrhosis-59
- Conditions
- Liver Cirrhosis, Spontaneous Bacterial Peritonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Sep 2023 (actual)
- 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.
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined, which decreases the morbidity and mortality. However the conventional dose recommended by the guidelines is usually not tolerated by the Indian population. Investigator propose that the low dose is as beneficial as the standard dose in patients with high risk SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk spontaneous bacterial peritonitis. If confirmed, these results could support a significant cost reduction in the management of ascites in cirrhotic patients and decrease the side effects of the volume overload in the patient of the cirrhosis.
Detailed description
Hypothesis Alternate Hypothesis: Low dose albumin is as effective as conventional dose albumin in cirrhosis with high risk SBP patients having AKI development or progression by day 4.
Aim:-To compare the efficacy and safety of low dose albumin with conventional dose albumin in AKI development or progression in patients with cirrhosis and high risk spontaneous bacterial peritonitis.
Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/ICU diagnosed with high risk SBP.
Study design: Randomized controlled trial Study period:1.5year Sample size: 300 (150 cases in each group) Assuming that the rate of AKI development in conventional dose albumin group - 10% and low dose albumin group 15%, Power- 80%, Alpha- 10% ONE SIDED, Non inferiority limit- 5, cases needed to enroll are 270, further assuming 10% dropout, investigator decided to enroll total 300 cases, randomly allocated with 150 cases in each arm by block randomization method with Block size of 10 Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.
STATISTICAL ANALYSIS:
Continuous variables- Mean +/- SD Categorical variables as percentages (%) or Frequencies Student t test will be applied in continuous data compared with two groups Survival analysis like Cox-Regression model and Kaplan-Meir plots will be plotted to find the possible factors responsible for mortality Besides these, Intent to treat (ITT) and Per Protocol (PP) will be done at the time of data analysis.
Adverse effects:
Patients receiving Albumin may experience Nausea, Vomiting, Fever with chills, dyspnea Wheezing, Volume overload, Anaphylactic reaction
Stopping rule of study:
Adverse reaction to drug Cardiopulmonary compromise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Arm+Standard Medical therapy | Active comparator | Biological: 20% High Dose Albumin, Other: Standard Medical TreatmentHuman Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg body weight (Maximum 100g)on day 3 along with standard medical therapy. |
| Reduced Dose Albumin+Standard Medical therapy | Experimental | Other: Standard Medical Treatment, Biological: 20% Reduced Dose AlbuminHuman Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18years
- Cirrhosis with SBP (community acquired /Health care associated/ nosocomial)
- High risk SBP : Patients with S Bil >4 mg/dL and/or s creat > 1 mg/dl at presentation
Key exclusion criteria (10 listed)
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known CKD or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV infection
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% High Dose AlbuminA]. Patients in the conventional albumin Arm will receive Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg bodyweight (Maximum 100g)on day 3 along with standard medical therapy. Duration of albumin over 24 hours. | Biological | High Dose Arm+Standard Medical therapy |
| Standard Medical TreatmentStandard Medical Treatment | Other | High Dose Arm+Standard Medical therapy, Reduced Dose Albumin+Standard Medical therapy |
| 20% Reduced Dose AlbuminB]. Patients in the low dose albumin Arm will receive Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy. Duration of albumin over 24 hours. | Biological | Reduced Dose Albumin+Standard Medical therapy |
Primary outcome
Proportion of patients developing new AKI or having progression of AKI by day 4.
Time frame: Day 4
15 secondary outcomes
Resolution of Spontaneous Bacterial Peritonitis by day 5
Time frame: Day 5
Change on Serum Ascites Albumin Gradient (SAAG) in both the groups.
Time frame: Day 5
Change in cell count (PMN) in both groups.
Time frame: Day 5
Changes in PRA levels from baseline to day 7
Time frame: day 7
Changes in TNF-alpha levels from baseline to day 7
Time frame: day 7
Changes in IL-6 levels from baseline to day 7
Time frame: day 7
Changes in endotoxin levels from baseline to day 7
Time frame: day 7
Changes in renal resistive index from baseline to day 7
Time frame: day 7
Number of patients with development of complications in both groups
Time frame: 90 days
Number of Participants with changes in ProBNP from baseline to day 4 or if shortness of breath occurs
Time frame: Day 4
Number of Participants with changes in vWF-Ag from baseline to day 4
Time frame: Day 4
Number of patients expired in both the groups
Time frame: Day 7
Number of patients expired in both the groups
Time frame: Day 28
Number of patients expired in both the groups
Time frame: Day 90
Duration of hospital stay
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
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% High Dose Albumin, Standard Medical Treatment and 20% Reduced Dose Albumin in people with Liver Cirrhosis and Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India 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 10 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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. 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?
Contact Dr Saurav Paul, MD (01146300000, saurav.paul79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients developing new AKI or having progression of AKI by day 4. (time frame: Day 4). 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 9 Aug 2024.