On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis
- Conditions
- Acute Kidney Injury With Cirrhosis
- Interventions
- Biological: Protocol Guided Renal Replacement TherapyBiological: On Demand Renal Replacement Therapy
- Registration Number
- NCT02937935
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protocol Guided-RRT 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. On Demand-RRT On Demand Renal Replacement Therapy 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
- Primary Outcome Measures
Name Time Method Recovery of renal functions in both groups day 14
- Secondary Outcome Measures
Name Time Method Mortality in both groups 3 month Improvement in SOFA (by 2 points) scores in both groups 48 hours Improvement in MELD ( by 2 points) scores in both groups 48 hours Improvement in APACHE ( by 2 points) scores in both groups 48 hours Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups 4 weeks Improvement in renal functions in both groups 7 days Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups. 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 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 24 hours Response as assessed by either improvement in urine output \>0.5ml/kg/hour, acid-base status or renal functions.
Adverse effects of dialysis in the first session in both groups 48 hours
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India