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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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.
Patients to be randomized to the intervention as per standard of care
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Recovery of renal functions in both groups
Time frame: day 14
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.
Response as assessed by either improvement in urine output \>0.5ml/kg/hour, acid-base status or renal functions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
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