Cirrhotics With Septic Shock and Acute Kidney InjuryNCT02937961
Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury
A study testing Early SLED and Late SLED in people with Cirrhotics With Septic Shock and Acute Kidney Injury, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Consecutive patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhotics With Septic Shock and Acute Kidney Injury
- What is being tested?
- Early SLED and Late SLED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2017to 1 Mar 2019
- 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
- Patients with Cirrhosis with septic shock associated AKI (Acute Kidney Injury) stage 3 AKIN/KDIGO stage 2.
Who cannot join
- Patients with age less than 18 years
- Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, Coronary Obstructive Pulmonary Disease)
- Pregnancy
- Chronic kidney disease on hemodialysis
- Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to suspected based on history,urinalysis and past clinical records-glomerulonephritis, interstitial nephritis or vasculitis
- Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (serum potassium>6 meq/lt, metabolic acidosis ph<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
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- Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Failure to give informed consent from family members.
- Hemodynamic instability requiring very high dose of vasopressors
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury -A Pilot Randomized Controlled Trial
Consecutive patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.
- Being tested
- Early SLED, Late SLED
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early SLEDBiological
withing 6 to 12 hours
Late SLEDBiological
when absolute indications will meet
| Study group | Role | What they receive |
|---|---|---|
| Early SLED | Experimental | Not described Receives: Biological: Early SLED |
| Late SLED | Active comparator | Not described Receives: Biological: Late SLED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival in both groups
Measured: 28 days
Secondary outcomes (15)
Incidence of intradialytic hypotension in both groups
Measured: 48 hours
Hemodynamic stability in both groups
Measured: 48 hours
Dialysis efficiency as measured by Urea Reduction ratio in both groups
Measured: 2 days
Achievement of target ultrafiltration goals in both groups
Measured: 48 hours
Recovery in renal functions in both groups
Recovery is defined as an increase in urine output to more than 400 ml/day
Measured: 14 days
Duration of Intensive Care Unit stay in both groups
Measured: 28 days
Duration of mechanical ventilation in both groups
Measured: 28 days
Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups
Measured: 28 days
Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores
Measured: 28 days
Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores
Measured: 28 days
Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups
Measured: 6 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Measured: 12 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Measured: 24 hours
Death related with renal failure in both groups
Measured: 7 day
Mortality due to renal failure related in both groups.
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start1 Dec 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cirrhotics With Septic Shock and Acute Kidney InjuryStudies 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
- 150 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
- NCT02937961
- Sponsor's protocol ID
- ILBS-Septic Shock-001
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2016
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maiwall R, Pasupuleti SSR, Agarwal P, Thomas S, Tevethia HV, Mathur RP, Sarin SK. Early Versus Late Dialysis in Cirrhosis Patients and Septic Shock (ELDICS Study): A Randomized Controlled Trial (NCT02937961). JGH Open. 2025 Sep 24;9(9):e70216. doi: 10.1002/jgh3.70216. eCollection 2025 Sep.
PubMed 41020192Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
PubMed 36416787
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury -A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02937961
- Acronym / sponsor ID
- ILBS-Septic Shock-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 19 Oct 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 patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early SLED | Experimental | Biological: Early SLED |
| Late SLED | Active comparator | Biological: Late SLED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Cirrhosis with septic shock associated AKI (Acute Kidney Injury) stage 3 AKIN/KDIGO stage 2.
Key exclusion criteria (10 listed)
- Patients with age less than 18 years
- Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, Coronary Obstructive Pulmonary Disease)
- Pregnancy
- Chronic kidney disease on hemodialysis
- Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to suspected based on history,urinalysis and past clinical records-glomerulonephritis, interstitial nephritis or vasculitis
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 |
|---|---|---|
| Early SLEDwithing 6 to 12 hours | Biological | Early SLED |
| Late SLEDwhen absolute indications will meet | Biological | Late SLED |
Primary outcome
Transplant free survival in both groups
Time frame: 28 days
15 secondary outcomes
Incidence of intradialytic hypotension in both groups
Time frame: 48 hours
Hemodynamic stability in both groups
Time frame: 48 hours
Dialysis efficiency as measured by Urea Reduction ratio in both groups
Time frame: 2 days
Achievement of target ultrafiltration goals in both groups
Time frame: 48 hours
Recovery in renal functions in both groups
Time frame: 14 days
Duration of Intensive Care Unit stay in both groups
Time frame: 28 days
Duration of mechanical ventilation in both groups
Time frame: 28 days
Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups
Time frame: 28 days
Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores
Time frame: 28 days
Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores
Time frame: 28 days
Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups
Time frame: 6 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Time frame: 12 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Time frame: 24 hours
Death related with renal failure in both groups
Time frame: 7 day
Mortality due to renal failure related in both groups.
Time frame: 7 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 41020192Maiwall R, Pasupuleti SSR, Agarwal P, Thomas S, Tevethia HV, Mathur RP, Sarin SK. Early Versus Late Dialysis in Cirrhosis Patients and Septic Shock (ELDICS Study): A Randomized Controlled Trial (NCT02937961). JGH Open. 2025 Sep 24;9(9):e70216. doi: 10.1002/jgh3.70216. eCollection 2025 Sep.
- Derived from this study: PubMed 36416787Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
- Individual participant dataSharing planned: No
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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 Early SLED and Late SLED in people with Cirrhotics With Septic Shock and Acute Kidney Injury, 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 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 7 Mar 2019. 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 Rakhi Maiwall, MD,DM (01146300000, rakhi_2011@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free survival in both groups (time frame: 28 days). 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 NCT02937961, which also lists 2 linked publications.
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 7 Mar 2019.