Cirrhosis With SepsisNCT02721238
Comparison of Colloid (20% Albumin) Versus Crystalloid (Plasmalyte) for Fluid Resuscitation in Cirrhotics With Sepsis Induced Hypotension.
A study testing 20% Albumin and Plasmalyte in people with Cirrhosis With Sepsis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Consecutive cirrhotics who present to emergency department of Institute of Liver \& Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis With Sepsis
- What is being tested?
- 20% Albumin and Plasmalyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2016to 3 Nov 2018
- 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
- Patients of cirrhosis with suspected or documented sepsis with MAP < 65 mm Hg
Who cannot join
- Age <18 years or > 75 yrs
- Already received colloid or 2 litres of fluid within the first 12 hours of presentation
- Already on vasopressors and/or inotropes
- Patients with Spontaneous Bacterial Peritonitis and serum albumin less then 1.5g/dl
- Patient with structural heart disease
- On maintenance hemodialysis
Show all 11Show fewer
- Other causes of hypotension
- Pregnant or lactating women
- Patients in need for emergent surgical interventions
- Known chronic obstructive lung disease and congestive heart failure
- A previous adverse reaction to human albumin solution
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Consecutive cirrhotics who present to emergency department of Institute of Liver \& Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. The aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after one week will be studied.
- Conditions
- Cirrhosis With Sepsis
- Being tested
- 20% Albumin, Plasmalyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% AlbuminBiological
PlasmalyteOther
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation with 30ml/kg plasmalyte | Active comparator | Not described Receives: Other: Plasmalyte |
| Resuscitation with 20% Albumin | Experimental | Not described Receives: Biological: 20% Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of hypotension in both groups
Reversal is defined as Mean Arterial Pressure (MAP) > 65 mmHg after 3 hours of resuscitation
Measured: 3 hours
Secondary outcomes (6)
Mortality in both groups
Measured: 7 days
Survival time during the first 28 days
Measured: 28 days
Proportion of patients with new organ failures.
Measured: 28 days
Duration of mechanical ventilation.
Measured: 28 days
Requirement of renal-replacement therapy.
Renal-replacement therapy. is defined as patients who required hemodialysis , SLED (Sustained Low efficiency Dialysis) or CRRT (Continous renal replacement therapy).
Measured: 28 days
The duration of the Intensive Care Unit stay.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start1 Dec 2016
- Primary completion3 Nov 2018
- Study completion3 Nov 2018
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 Cirrhosis With SepsisStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Abhinav Verma, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721238
- Sponsor's protocol ID
- ILBS-Cirrhosis-03
- Status last verified
- Aug 2021
- First submitted
- 1 Mar 2016
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Maiwall R, Kumar A, Pasupuleti SSR, Hidam AK, Tevethia H, Kumar G, Sahney A, Mitra LG, Sarin SK. A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]. J Hepatol. 2022 Sep;77(3):670-682. doi: 10.1016/j.jhep.2022.03.043. Epub 2022 Apr 20.
PubMed 35460725
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Colloid (20% Albumin) Versus Crystalloid (Plasmalyte) for Fluid Resuscitation in Cirrhotics With Sepsis Induced Hypotension.
- ClinicalTrials.gov ID
- NCT02721238
- Acronym / sponsor ID
- ILBS-Cirrhosis-03
- Conditions
- Cirrhosis With Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 3 Nov 2018 (actual)
- Study completion
- 3 Nov 2018 (actual)
- First posted
- 29 Mar 2016 (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.
Consecutive cirrhotics who present to emergency department of Institute of Liver \& Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. The aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after one week will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resuscitation with 30ml/kg plasmalyte | Active comparator | Other: Plasmalyte |
| Resuscitation with 20% Albumin | Experimental | Biological: 20% Albumin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of cirrhosis with suspected or documented sepsis with MAP < 65 mm Hg
Key exclusion criteria (11 listed)
- Age <18 years or > 75 yrs
- Already received colloid or 2 litres of fluid within the first 12 hours of presentation
- Already on vasopressors and/or inotropes
- Patients with Spontaneous Bacterial Peritonitis and serum albumin less then 1.5g/dl
- Patient with structural heart disease
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% Albumin | Biological | Resuscitation with 20% Albumin |
| Plasmalyte | Other | Resuscitation with 30ml/kg plasmalyte |
Primary outcome
Reversal of hypotension in both groups
Time frame: 3 hours
Reversal is defined as Mean Arterial Pressure (MAP) > 65 mmHg after 3 hours of resuscitation
6 secondary outcomes
Mortality in both groups
Time frame: 7 days
Survival time during the first 28 days
Time frame: 28 days
Proportion of patients with new organ failures.
Time frame: 28 days
Duration of mechanical ventilation.
Time frame: 28 days
Requirement of renal-replacement therapy.
Time frame: 28 days
The duration of the Intensive Care Unit stay.
Time frame: 28 days
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 26 Aug 2021.
- Derived from this study: PubMed 35460725Maiwall R, Kumar A, Pasupuleti SSR, Hidam AK, Tevethia H, Kumar G, Sahney A, Mitra LG, Sarin SK. A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]. J Hepatol. 2022 Sep;77(3):670-682. doi: 10.1016/j.jhep.2022.03.043. Epub 2022 Apr 20.
- Individual participant dataSharing planned: Undecided
Related trials for Cirrhosis With Sepsis
Active, not recruitingEarly Phase 1
Comparison of Angiotensin II to Standard Dose Vasopressors on Change in Arterial Elastance
Septic Shock, Cirrhosis
Not yet recruitingObservational study
Cohort Study of Chronic Liver Disease Complicated by Sepsis
Cirrhosis, Sepsis
Recruiting
Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis
Cirrhosis, Liver, Cirrhotic Cardiomyopathy
Not yet recruiting
Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis and Sepsis Associated Acute Kidney Injury
Liver Cirrhosis, Acute Kidney Injury
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.
Dr Abhinav Verma, MD principal investigator
Institute of Liver and Biliary Sciences, India
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% Albumin and Plasmalyte in people with Cirrhosis With Sepsis, 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 1 inclusion and 11 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 26 Aug 2021. 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?
Reversal of hypotension in both groups (time frame: 3 hours). 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 NCT02721238, 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 26 Aug 2021.