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On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis

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ClinicalTrials.gov Identifier: NCT02937935
Recruitment Status : Unknown
Verified November 2017 by Institute of Liver and Biliary Sciences, India.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2016
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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Brief 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). 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.

  1. 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
  2. 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

Condition or disease Intervention/treatment Phase
Acute Kidney Injury With Cirrhosis Biological: Protocol Guided Renal Replacement Therapy Biological: On Demand Renal Replacement Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Protocol Guided-RRT
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.
 Biological: Protocol Guided Renal Replacement Therapy
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.
Active Comparator: On Demand-RRT
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
 Biological: On Demand Renal Replacement Therapy
Patients to be randomized to the intervention as per standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Recovery of renal functions in both groups [ Time Frame: day 14 ]

Secondary Outcome Measures :
  1. Adverse effects of dialysis in the first session in both groups [ Time Frame: 48 hours ]
  2. Improvement in SOFA (by 2 points) scores in both groups [ Time Frame: 48 hours ]
  3. Improvement in MELD ( by 2 points) scores in both groups [ Time Frame: 48 hours ]
  4. Improvement in APACHE ( by 2 points) scores in both groups [ Time Frame: 48 hours ]
  5. Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups [ Time Frame: 4 weeks ]
  6. Improvement in renal functions in both groups [ Time Frame: 7 days ]
  7. Mortality in both groups [ Time Frame: 1 month ]
  8. Mortality in both groups [ Time Frame: 3 month ]
  9. Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups. [ Time Frame: 6 hours ]
    Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.

  10. Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups. [ Time Frame: 12 hours ]
    Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.

  11. Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury [ Time Frame: 24 hours ]
    Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.

  12. Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups [ Time Frame: 24 hours ]
    Response as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937935


Contacts
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Contact: Dr Rakhi Maiwall, MD,DM 01146300000 rakhi_2011@yahoo.co.in

Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02937935    
Other Study ID Numbers: ILBS-AKI-Cirrhosis
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Acute Kidney Injury
Fibrosis
Wounds and Injuries
Pathologic Processes
 Liver Diseases
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases