Septic Shock and Acute Kidney InjuryNCT03343340
Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI
A study testing Early CRRT, Late CRRT and Standard Medical Therapy in people 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 ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock and Acute Kidney Injury
- What is being tested?
- Early CRRT, Late CRRT and Standard Medical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 25 Sep 2017to 25 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ACLF defined based on APASL criteria with septic shock associated AKI
Who cannot join
- 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 with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to 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 CRRT (Continuous Renal Replacement Therpay) in ACLF (Acute on Chronic Liver Failure) Patients With Septic Shock and AKI (Acute Kidney Injury) - A Randomized Controlled Trial
Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. 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, 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.
- Conditions
- Septic Shock and Acute Kidney Injury
- Being tested
- Early CRRT, Late CRRT, Standard Medical Therapy
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early CRRTOther
Continous Renal Replacement Therapy
Late CRRTOther
Continous Renal Replacement Therapy
Standard Medical TherapyOther
Standard Medical Therapy
| Study group | Role | What they receive |
|---|---|---|
| Early CRRT | Experimental | Early Continous Renal Replacement Therapy within 6 hours + Standard Medical Therapy Receives: Other: Early CRRT; Other: Standard Medical Therapy |
| Late CRRT | Active comparator | Late Continous Renal Replacement Therapy + Standard Medical Therapy Receives: Other: Late CRRT; Other: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant Free Survival
Measured: 28 days
Secondary outcomes (12)
Incidence of intradialytic hypotension i.e. defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by 10 mm Hg associated with symptoms
Measured: 1 year
Hemodynamic stability i.e. maintenance of MAP on dialysis without increase in the vasopressors
Measured: 1 year
Dialysis efficiency as measured by Urea Reduction ratio at 48 hours
Measured: 2 days
Achievement of target ultrafiltration goals
Measured: 1 year
Recovery in renal functions defined as an increase in urine output to more than 400 ml/day
Measured: 1 year
Duration of mechanical ventilation and ICU (Intensive Care Unit) stay
Measured: 1 year
Improvement in SOFA (Sequential Organ Failure Assessment ) ( by 2 points) scores
Measured: 1 year
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) ( by 2 points) scores
Measured: 1 year
Improvement in MELD (Model for End Stage Liver Disease) ( by 2 points) scores
Measured: 1 year
Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CRRT
Measured: within 6 hours
Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CRRT
Measured: within 12 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CRRT
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start25 Sep 2017
- Primary completion25 Sep 2018 (estimated)
- Study completion25 Sep 2018 (estimated)
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 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
- NCT03343340
- Sponsor's protocol ID
- ILBS-CRRT-01
- Status last verified
- Sep 2017
- First submitted
- 23 Sep 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fayad 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 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late CRRT (Continuous Renal Replacement Therpay) in ACLF (Acute on Chronic Liver Failure) Patients With Septic Shock and AKI (Acute Kidney Injury) - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03343340
- Acronym / sponsor ID
- ILBS-CRRT-01
- Conditions
- Septic Shock and Acute Kidney Injury
- 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
- 25 Sep 2017 (actual)
- Primary completion
- 25 Sep 2018 (estimated)
- Study completion
- 25 Sep 2018 (estimated)
- First posted
- 17 Nov 2017 (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.
Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. 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, 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 CRRT | Experimental | Other: Early CRRT, Other: Standard Medical TherapyEarly Continous Renal Replacement Therapy within 6 hours + Standard Medical Therapy |
| Late CRRT | Active comparator | Other: Late CRRT, Other: Standard Medical TherapyLate Continous Renal Replacement Therapy + Standard Medical Therapy |
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 ACLF defined based on APASL criteria with septic shock associated AKI
Key exclusion criteria (10 listed)
- 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 with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to 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 CRRTContinous Renal Replacement Therapy | Other | Early CRRT |
| Late CRRTContinous Renal Replacement Therapy | Other | Late CRRT |
| Standard Medical TherapyStandard Medical Therapy | Other | Early CRRT, Late CRRT |
Primary outcome
Transplant Free Survival
Time frame: 28 days
12 secondary outcomes
Incidence of intradialytic hypotension i.e. defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by 10 mm Hg associated with symptoms
Time frame: 1 year
Hemodynamic stability i.e. maintenance of MAP on dialysis without increase in the vasopressors
Time frame: 1 year
Dialysis efficiency as measured by Urea Reduction ratio at 48 hours
Time frame: 2 days
Achievement of target ultrafiltration goals
Time frame: 1 year
Recovery in renal functions defined as an increase in urine output to more than 400 ml/day
Time frame: 1 year
Duration of mechanical ventilation and ICU (Intensive Care Unit) stay
Time frame: 1 year
Improvement in SOFA (Sequential Organ Failure Assessment ) ( by 2 points) scores
Time frame: 1 year
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) ( by 2 points) scores
Time frame: 1 year
Improvement in MELD (Model for End Stage Liver Disease) ( by 2 points) scores
Time frame: 1 year
Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CRRT
Time frame: within 6 hours
Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CRRT
Time frame: within 12 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CRRT
Time frame: within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- 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.
Related trials for Septic Shock and Acute Kidney Injury
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
Recruiting
Early Endotoxin Burden Reduction With oXiris in Septic Shock Patients Requiring CRRT
Septic Shock, Acute Kidney Injury
RecruitingObservational study
Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock?
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Comparison of Angiotensin II to Standard Dose Vasopressors on Change in Arterial Elastance
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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 CRRT, Late CRRT and Standard Medical Therapy in people 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 17 Nov 2017. 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 (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 NCT03343340, 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 17 Nov 2017.