Spontaneous Bacterial PeritonitisNCT04273373
Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
A study testing Low Dose Albumin and Standard dose Albumin in people with Spontaneous Bacterial Peritonitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk Spontaneous Bacterial Peritonitis. Methodology In this non-inferior randomized controlled trial one group will receive Low dose albumin: 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours and other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Low Dose Albumin and Standard dose Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2020to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or SCr ≥ 1 mg/dl.
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 ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV (Human Immunodeficiency Virus) infection;
- GI (Gastrointestinal) bleed within 1 month before the study
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- Ileus
- Grade 3 to 4 hepatic encephalopathy
- Other types of infection
- Shock
- Presence of any potential causes of dehydration (such as diarrhoea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).
- Baseline serum bilirubin <4 mg/dl or S. Cr < 1 mg/dl
- Serum creatinine level of > 3.0 mg/dl.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Randomized Non-inferiority Trial Comparing Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk Spontaneous Bacterial Peritonitis.
Methodology In this non-inferior randomized controlled trial one group will receive Low dose albumin: 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours and other group will receive Standard dose albumin: 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 h (duration of infusion 6 hours).
Read more
Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/Intensive Care Unit diagnosed with Spontaneous Bacterial Peritonitis.
Study design: Randomized controlled trial Study period: September 2019- September 2020 Sample size: 300 (150 cases in each group) If there is a true difference in favour of the experimental treatment of 5 % then 270 patients are required to be 80% sure that the upper limit of a one sided 95% confidence interval (or equivalently a 90 % two-sided confidence interval) will exclude a difference in favour of the standard group of more than 5 %. And if the investigators consider 10% drop out final sample size is 270+30=300. 150 in each limb. Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.
Monitoring and assessment: all the parameters of the objective and also noted any adverse effects.
Adverse Effects: Nausea, Vomiting, Fever with chills, dyspnea Stopping Rule: in the event of any of the adverse effects during therapy.
Expected Outcome of the project:
Proportion of patients having new development or progression of Acute Kidney Injury by day 7
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Low Dose Albumin, Standard dose Albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose AlbuminBiological
20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours
Standard dose AlbuminBiological
20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours (duration of infusion 6 hours).
| Study group | Role | What they receive |
|---|---|---|
| Standard dose albumin+SOC | Active comparator | 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours. SOC (Standard of Care) Receives: Biological: Standard dose Albumin |
| Low dose albumin+SOC | Experimental | 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg. after 48 hours SOC (Standard of Care) Receives: Biological: Low Dose Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having new development or progression of Acute Kidney Injury in both groups
Measured: Day 7
Secondary outcomes (5)
Number of participants with resolution of Spontaneous Bacterial Peritonitis in both groups
Measured: Day 7
Changes in RRI (Renal Resistive Index) in both groups
Measured: Day 6
Number of participants who will develop volume overload in both groups
Measured: Day 7
Number of participants who will not survive in both groups.
Measured: Day 7
Number of participants who will not survive in both groups.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Bacterial PeritonitisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
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
- NCT04273373
- Sponsor's protocol ID
- ILBS-AKI-03
- Status last verified
- May 2022
- First submitted
- 12 Feb 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kar PS, Venishetty S, Laroia ST, Jindal A, Maiwall R, Sood AK, Shasthry SM, Rajan V, Arora V, Bhardwaj A, Kumar G, Kumar M. Tolerance of standard dose albumin infused over 6 hrs for treatment of spontaneous bacterial peritonitis-A randomized controlled trial. Indian J Gastroenterol. 2023 Aug;42(4):505-516. doi: 10.1007/s12664-023-01389-x. Epub 2023 Jul 8.
PubMed 37422602
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Non-inferiority Trial Comparing Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
- ClinicalTrials.gov ID
- NCT04273373
- Acronym / sponsor ID
- ILBS-AKI-03
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Feb 2020 (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.
AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk Spontaneous Bacterial Peritonitis.
Methodology In this non-inferior randomized controlled trial one group will receive Low dose albumin: 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours and other group will receive Standard dose albumin: 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 h (duration of infusion 6 hours).
Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/Intensive Care Unit diagnosed with Spontaneous Bacterial Peritonitis.
Study design: Randomized controlled trial Study period: September 2019- September 2020 Sample size: 300 (150 cases in each group) If there is a true difference in favour of the experimental treatment of 5 % then 270 patients are required to be 80% sure that the upper limit of a one sided 95% confidence interval (or equivalently a 90 % two-sided confidence interval) will exclude a difference in favour of the standard group of more than 5 %. And if the investigators consider 10% drop out final sample size is 270+30=300. 150 in each limb. Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.
Monitoring and assessment: all the parameters of the objective and also noted any adverse effects.
Adverse Effects: Nausea, Vomiting, Fever with chills, dyspnea Stopping Rule: in the event of any of the adverse effects during therapy.
Expected Outcome of the project:
Proportion of patients having new development or progression of Acute Kidney Injury by day 7
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose albumin+SOC | Active comparator | Biological: Standard dose Albumin20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours. SOC (Standard of Care) |
| Low dose albumin+SOC | Experimental | Biological: Low Dose Albumin20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg. after 48 hours SOC (Standard of Care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or SCr ≥ 1 mg/dl.
Key exclusion criteria (13 listed)
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known CKD ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV (Human Immunodeficiency Virus) 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 |
|---|---|---|
| Low Dose Albumin20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours | Biological | Low dose albumin+SOC |
| Standard dose Albumin20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours (duration of infusion 6 hours). | Biological | Standard dose albumin+SOC |
Primary outcome
Proportion of patients having new development or progression of Acute Kidney Injury in both groups
Time frame: Day 7
5 secondary outcomes
Number of participants with resolution of Spontaneous Bacterial Peritonitis in both groups
Time frame: Day 7
Changes in RRI (Renal Resistive Index) in both groups
Time frame: Day 6
Number of participants who will develop volume overload in both groups
Time frame: Day 7
Number of participants who will not survive in both groups.
Time frame: Day 7
Number of participants who will not survive in both groups.
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 37422602Kar PS, Venishetty S, Laroia ST, Jindal A, Maiwall R, Sood AK, Shasthry SM, Rajan V, Arora V, Bhardwaj A, Kumar G, Kumar M. Tolerance of standard dose albumin infused over 6 hrs for treatment of spontaneous bacterial peritonitis-A randomized controlled trial. Indian J Gastroenterol. 2023 Aug;42(4):505-516. doi: 10.1007/s12664-023-01389-x. Epub 2023 Jul 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Albumin and Standard dose Albumin in people with 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 10 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients having new development or progression of Acute Kidney Injury in both groups (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273373, which also lists 1 linked publication.
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 10 May 2022.