Clinical trial NCT02937961: Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury
Official title: Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury -A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhotics With Septic Shock and Acute Kidney Injury
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-10-19
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 cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. 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 on hemodialysis, 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 Cirrhosis with septic shock associated AKI (Acute Kidney Injury) stage 3 AKIN/KDIGO stage 2.

Exclusion Criteria:

* Patients with age less than 18 years
* Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, Coronary Obstructive Pulmonary Disease)
* Pregnancy
* Chronic kidney disease on hemodialysis
* Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to suspected based on history,urinalysis and past clinical records-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 in both groups
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of intradialytic hypotension in both groups
timeFrame: 48 hours
measure: Hemodynamic stability in both groups
timeFrame: 48 hours
measure: Dialysis efficiency as measured by Urea Reduction ratio in both groups
timeFrame: 2 days
measure: Achievement of target ultrafiltration goals in both groups
timeFrame: 48 hours
measure: Recovery in renal functions in both groups
timeFrame: 14 days
measure: Duration of Intensive Care Unit stay in both groups
timeFrame: 28 days
measure: Duration of mechanical ventilation in both groups
timeFrame: 28 days
measure: Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups
timeFrame: 28 days
measure: Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores
timeFrame: 28 days
measure: Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores
timeFrame: 28 days
measure: Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups
timeFrame: 6 hours
measure: Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
timeFrame: 12 hours
measure: Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
timeFrame: 24 hours
measure: Death related with renal failure in both groups
timeFrame: 7 day
measure: Mortality due to renal failure related in both groups.
timeFrame: 7 day
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: