Clinical trial NCT03343340: Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI
Official title: Early Versus Late CRRT (Continuous Renal Replacement Therpay) in ACLF (Acute on Chronic Liver Failure) Patients With Septic Shock and AKI (Acute Kidney Injury) - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock and Acute Kidney Injury
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, 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.


Eligibility criteria: Inclusion Criteria:

- Patients with ACLF defined based on APASL criteria with septic shock associated AKI

Exclusion Criteria:

* Patients with age less than 18 years
* Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
* Pregnancy
* Chronic kidney disease on hemodialysis
* Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to glomerulonephritis, interstitial nephritis or vasculitis
* Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (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: Transplant Free Survival
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of intradialytic hypotension i.e. defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by 10 mm Hg associated with symptoms
timeFrame: 1 year
measure: Hemodynamic stability i.e. maintenance of MAP on dialysis without increase in the vasopressors
timeFrame: 1 year
measure: Dialysis efficiency as measured by Urea Reduction ratio at 48 hours
timeFrame: 2 days
measure: Achievement of target ultrafiltration goals
timeFrame: 1 year
measure: Recovery in renal functions defined as an increase in urine output to more than 400 ml/day
timeFrame: 1 year
measure: Duration of mechanical ventilation and ICU (Intensive Care Unit) stay
timeFrame: 1 year
measure: Improvement in SOFA (Sequential Organ Failure Assessment ) ( by 2 points) scores
timeFrame: 1 year
measure: Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) ( by 2 points) scores
timeFrame: 1 year
measure: Improvement in MELD (Model for End Stage Liver Disease) ( by 2 points) scores
timeFrame: 1 year
measure: Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CRRT
timeFrame: within 6 hours
measure: Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CRRT
timeFrame: within 12 hours
measure: Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CRRT
timeFrame: within 24 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: