Acute Kidney Injury With CirrhosisNCT02937935
On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis
A study testing Protocol Guided Renal Replacement Therapy and On Demand Renal Replacement Therapy in people with Acute Kidney Injury With Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Intervention: All patients at presentation would be assessed for the underlying cause of and will be managed by removal of all precipitants(careful review of medications, diuretics, nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury With Cirrhosis
- What is being tested?
- Protocol Guided Renal Replacement Therapy and On Demand Renal Replacement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2018to 1 Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cirrhosis (diagnosed based on clinical, biochemical,radiological or histological diagnosis) with stage 3 Acute Kidney Injury defined as an increase of serum creatinine to more than 300 fold and more than 4 mg/dl.
Who cannot join
- Patients with age less than 18 years
- Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD Chronic Obstructive Pulmonary Disease)
- Pregnancy
- Chronic kidney disease on hemodialysis
- Patients with post renal obstructive AKI (Acute Kidney Injury), AKI (Acute Kidney Injury) suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization (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
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis -A Prospective Randomized Controlled Trial
Intervention: All patients at presentation would be assessed for the underlying cause of and will be managed by removal of all precipitants(careful review of medications, diuretics, nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step would be to consider plasma volume expansion in patients with hypovolemia (the choice of fluid could either be a crystalloid or albumin or even blood as indicated) along with identification and early treatment of bacterial infections. Along with this patients with a differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis of ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further, patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid resuscitation and vasoconstrictors would also be subjected to randomization.
- In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization
- In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions
- Conditions
- Acute Kidney Injury With Cirrhosis
- Being tested
- Protocol Guided Renal Replacement Therapy, On Demand Renal Replacement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol Guided Renal Replacement TherapyBiological
In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization.
On Demand Renal Replacement TherapyBiological
Patients to be randomized to the intervention as per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Protocol Guided-RRT | Experimental | In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization. Receives: Biological: Protocol Guided Renal Replacement Therapy |
| On Demand-RRT | Active comparator | In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions Receives: Biological: On Demand Renal Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of renal functions in both groups
Measured: day 14
Secondary outcomes (12)
Adverse effects of dialysis in the first session in both groups
Measured: 48 hours
Improvement in SOFA (by 2 points) scores in both groups
Measured: 48 hours
Improvement in MELD ( by 2 points) scores in both groups
Measured: 48 hours
Improvement in APACHE ( by 2 points) scores in both groups
Measured: 48 hours
Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups
Measured: 4 weeks
Improvement in renal functions in both groups
Measured: 7 days
Mortality in both groups
Measured: 1 month
Mortality in both groups
Measured: 3 month
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
Measured: 6 hours
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
Measured: 12 hours
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury
Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
Measured: 24 hours
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups
Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
Measured: 24 hours
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 Jul 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (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 Acute Kidney Injury With CirrhosisStudies of the same condition, open and under way.
- 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
- 2 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
- NCT02937935
- Sponsor's protocol ID
- ILBS-AKI-Cirrhosis
- Status last verified
- Nov 2017
- First submitted
- 17 Oct 2016
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis -A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02937935
- Acronym / sponsor ID
- ILBS-AKI-Cirrhosis
- Conditions
- Acute Kidney Injury With Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 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.
Intervention: All patients at presentation would be assessed for the underlying cause of and will be managed by removal of all precipitants(careful review of medications, diuretics, nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step would be to consider plasma volume expansion in patients with hypovolemia (the choice of fluid could either be a crystalloid or albumin or even blood as indicated) along with identification and early treatment of bacterial infections. Along with this patients with a differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis of ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further, patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid resuscitation and vasoconstrictors would also be subjected to randomization.
- In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization
- In the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol Guided-RRT | Experimental | Biological: Protocol Guided Renal Replacement TherapyIn the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization. |
| On Demand-RRT | Active comparator | Biological: On Demand Renal Replacement TherapyIn the protocol guided group patients all patients would be considered for dialysis within 6 hours of randomization After randomization patients would receive dialysis as three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration and/or diffusion in continuous form until recovery of renal functions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cirrhosis (diagnosed based on clinical, biochemical,radiological or histological diagnosis) with stage 3 Acute Kidney Injury defined as an increase of serum creatinine to more than 300 fold and more than 4 mg/dl.
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 Chronic Obstructive Pulmonary Disease)
- Pregnancy
- Chronic kidney disease on hemodialysis
- Patients with post renal obstructive AKI (Acute Kidney Injury), AKI (Acute Kidney Injury) suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
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 |
|---|---|---|
| Protocol Guided Renal Replacement TherapyIn the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization. | Biological | Protocol Guided-RRT |
| On Demand Renal Replacement TherapyPatients to be randomized to the intervention as per standard of care | Biological | On Demand-RRT |
Primary outcome
Recovery of renal functions in both groups
Time frame: day 14
12 secondary outcomes
Adverse effects of dialysis in the first session in both groups
Time frame: 48 hours
Improvement in SOFA (by 2 points) scores in both groups
Time frame: 48 hours
Improvement in MELD ( by 2 points) scores in both groups
Time frame: 48 hours
Improvement in APACHE ( by 2 points) scores in both groups
Time frame: 48 hours
Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups
Time frame: 4 weeks
Improvement in renal functions in both groups
Time frame: 7 days
Mortality in both groups
Time frame: 1 month
Mortality in both groups
Time frame: 3 month
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
Time frame: 6 hours
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
Time frame: 12 hours
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury
Time frame: 24 hours
Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
- 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 Protocol Guided Renal Replacement Therapy and On Demand Renal Replacement Therapy in people with Acute Kidney Injury With Cirrhosis, 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 29 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?
Recovery of renal functions in both groups (time frame: day 14). 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 NCT02937935, 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 29 Nov 2017.