Clinical trial NCT02937935: On Demand Versus Protocol-guided Renal Replacement Therapy for Management of Stage 3 Acute Kidney Injury in Patients With Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury With Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Recovery of renal functions in both groups
timeFrame: day 14
Secondary outcomes:
measure: Adverse effects of dialysis in the first session in both groups
timeFrame: 48 hours
measure: Improvement in SOFA (by 2 points) scores in both groups
timeFrame: 48 hours
measure: Improvement in MELD ( by 2 points) scores in both groups
timeFrame: 48 hours
measure: Improvement in APACHE ( by 2 points) scores in both groups
timeFrame: 48 hours
measure: Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups
timeFrame: 4 weeks
measure: Improvement in renal functions in both groups
timeFrame: 7 days
measure: Mortality in both groups
timeFrame: 1 month
measure: Mortality in both groups
timeFrame: 3 month
measure: Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
timeFrame: 6 hours
measure: Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups.
timeFrame: 12 hours
measure: Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury
timeFrame: 24 hours
measure: Response to vasoconstrictors in patients with Hepatorenal Syndrome-Acute Kidney Injury in both groups
timeFrame: 24 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: