Cirrhosis With Septic ShockNCT02462902
Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
A study testing 5% albumin Infusion and 0.9% sodium chloride solution in people with Cirrhosis With Septic Shock, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis With Septic Shock
- What is being tested?
- 5% albumin Infusion and 0.9% sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2014to Jun 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg
Who cannot join
- Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes
- Cirrhosis patients in septic shock with structural heart disease
- Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state
- Cirrhosis patients in shock, caused by other reasons, other than septic shock
- Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present
- Age less than 18 years
Show all 12Show fewer
- Previous episode of septic shock during the same hospital stay
- Pregnant or lactating women
- Patients in need for emergent surgical interventions
- Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure
- Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products
- A previous adverse reaction to human albumin solution
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
300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.
This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).
- Conditions
- Cirrhosis With Septic Shock
- Being tested
- 5% albumin Infusion, 0.9% sodium chloride solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% albumin InfusionDrug
colloid, 5% albumin (250 ml over 15 to 30 minutes).
0.9% sodium chloride solutionDrug
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| 5% albumin Infusion | Experimental | (250 ml over 15 to 30 minutes) Receives: Drug: 5% albumin Infusion |
| 0.9% sodium chloride solution | Active comparator | 0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute) Receives: Drug: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of patients with MAP (Mean Arterial Pressure) ≥ 65
Measured: 3 hours
Secondary outcomes (3)
Change in lactate dynamics
Measured: 3 hours
Total number of patients with Urine output >/= 0.5mL/kg/hr.
Measured: 3 hours
Mortality
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis With Septic ShockStudies 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
- 308 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
- NCT02462902
- Sponsor's protocol ID
- ILBS-Cirrhosis with sepsis-01
- Status last verified
- May 2015
- First submitted
- 25 May 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
- ClinicalTrials.gov ID
- NCT02462902
- Acronym / sponsor ID
- ILBS-Cirrhosis with sepsis-01
- Conditions
- Cirrhosis With Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Jun 2015 (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.
300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.
This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% albumin Infusion | Experimental | Drug: 5% albumin Infusion(250 ml over 15 to 30 minutes) |
| 0.9% sodium chloride solution | Active comparator | Drug: 0.9% sodium chloride solution0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg
Key exclusion criteria (12 listed)
- Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes
- Cirrhosis patients in septic shock with structural heart disease
- Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state
- Cirrhosis patients in shock, caused by other reasons, other than septic shock
- Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present
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 |
|---|---|---|
| 5% albumin Infusioncolloid, 5% albumin (250 ml over 15 to 30 minutes). | Drug | 5% albumin Infusion |
| 0.9% sodium chloride solution0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes) | Drug | 0.9% sodium chloride solution |
Primary outcome
Total number of patients with MAP (Mean Arterial Pressure) ≥ 65
Time frame: 3 hours
3 secondary outcomes
Change in lactate dynamics
Time frame: 3 hours
Total number of patients with Urine output >/= 0.5mL/kg/hr.
Time frame: 3 hours
Mortality
Time frame: 7 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 30 Dec 2015.
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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 5% albumin Infusion and 0.9% sodium chloride solution in people with Cirrhosis With Septic Shock, 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 12 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 30 Dec 2015. 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?
Total number of patients with MAP (Mean Arterial Pressure) ≥ 65 (time frame: 3 hours). 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 30 Dec 2015.