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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

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date November 29, 2017
Estimated Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Recovery of renal functions in both groups [ Time Frame: day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2016)
  • 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 as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Adverse effects of dialysis in the first session in both groups [ Time Frame: 1 year ]
  • Improvement in SOFA (by 2 points) scores in both groups [ Time Frame: 1 year ]
  • Improvement in MELD ( by 2 points) scores in both groups [ Time Frame: 1 year ]
  • Improvement in APACHE ( by 2 points) scores in both groups [ Time Frame: 1 year ]
  • Change to End Stage Renal Disease with requirement of maintenance hemodialysis atleast 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 as assessed by either improvement in urine output >0.5ml/kg/hour, acid-base status or renal functions.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury With Cirrhosis
Intervention  ICMJE
  • 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.
  • Biological: On Demand Renal Replacement Therapy
    Patients to be randomized to the intervention as per standard of care
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Protocol Guided Renal Replacement Therapy
  • 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
    Intervention: Biological: On Demand Renal Replacement Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 22, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
150
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02937935
Other Study ID Numbers  ICMJE ILBS-AKI-Cirrhosis
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institute of Liver and Biliary Sciences, India
Study Sponsor  ICMJE Institute of Liver and Biliary Sciences, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Liver and Biliary Sciences, India
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP