Acute Kidney Injury With Cirrhosis Clinical Trial
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
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
| Status | Not yet recruiting |
| Enrollment | 2 |
| Est. completion date | July 1, 2019 |
| Est. primary completion date | July 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver and Biliary Sciences | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recovery of renal functions in both groups | day 14 | ||
| Secondary | Adverse effects of dialysis in the first session in both groups | 48 hours | ||
| Secondary | Improvement in SOFA (by 2 points) scores in both groups | 48 hours | ||
| Secondary | Improvement in MELD ( by 2 points) scores in both groups | 48 hours | ||
| Secondary | Improvement in APACHE ( by 2 points) scores in both groups | 48 hours | ||
| Secondary | Change to End Stage Renal Disease with requirement of maintenance hemodialysis at least twice a week in both groups | 4 weeks | ||
| Secondary | Improvement in renal functions in both groups | 7 days | ||
| Secondary | Mortality in both groups | 1 month | ||
| Secondary | Mortality in both groups | 3 month | ||
| Secondary | 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. | 6 hours | |
| Secondary | 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. | 12 hours | |
| Secondary | 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. | 24 hours | |
| Secondary | 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. | 24 hours |