Status:
COMPLETED
Sustained Low Efficiency Dialysis Versus Continuous Renal Replacement Therapy for Acute Kidney Injury in Critically Ill Cirrhotics
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The current prospective pliot randomized controlled trial has been designed to demonstrate non-inferiority of sustained low efficiency dialysis (SLED) when compared to continuous renal replacement the...
Detailed Description
Aim \& Objectives Primary objective To study the efficacy of sustained low efficiency dialysis versus continuous renal replacement therapy in cirrhotics with septic shock and severe AKI Secondary Ob...
Eligibility Criteria
Inclusion
- \- Critically ill cirrhotics with septic shock defined as need of vasopressors to maintain MAP\> 65 mm Hg and lacate \>2 mmol/L despite adequate fluid resuscitation with severe AKI meeting criteria for dialysis
Exclusion
- Patients with age less than 18 years or more than 65 years
- Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD, CKD)
- Patients with ACLF
- Patients with cerebral edema
- Patients with refractory shock i.e. requiring norepinephrine or equivalent \>0.5ug/kg/min
- Severe coagulopathy platelets \<20,000 and INR \>4
- Active Bleed (Mucosal or variceal)
- Pregnancy
- Patients with moderate-severe ARDS i.e. Pa02/Fio2 ratio \<200
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Failure to give informed consent from family members.
- Patient enrolled in other clinical trials
- Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- Patients who have already been on hemodialysis before their arrival in the intensive care unit
- Patients with severe vasodilatation SVR \<400 dyn·s/cm5 and/or lactate \> 5 mmol/L
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04494542
Start Date
October 16 2020
End Date
May 16 2023
Last Update
November 3 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070