Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI

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

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock and Acute Kidney Injury
• Intervention / Treatment: Other: Early CRRT; Other: Standard Medical Therapy; Other: Late CRRT

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Rakhi Maiwall, MD,DM; Phone Number: 01146300000; Email: rakhi_2011@yahoo.co.in

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early CRRT; Early Continous Renal Replacement Therapy within 6 hours + Standard Medical Therapy	Other: Early CRRT; Continous Renal Replacement Therapy; Other: Standard Medical Therapy; Standard Medical Therapy
Active Comparator: Late CRRT; Late Continous Renal Replacement Therapy + Standard Medical Therapy	Other: Standard Medical Therapy; Standard Medical Therapy; Other: Late CRRT; Continous Renal Replacement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transplant Free Survival	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	1 year
Hemodynamic stability i.e. maintenance of MAP on dialysis without increase in the vasopressors	1 year
Dialysis efficiency as measured by Urea Reduction ratio at 48 hours	2 days
Achievement of target ultrafiltration goals	1 year
Recovery in renal functions defined as an increase in urine output to more than 400 ml/day	1 year
Duration of mechanical ventilation and ICU (Intensive Care Unit) stay	1 year
Improvement in SOFA (Sequential Organ Failure Assessment ) ( by 2 points) scores	1 year
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) ( by 2 points) scores	1 year
Improvement in MELD (Model for End Stage Liver Disease) ( by 2 points) scores	1 year
Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CRRT	within 6 hours
Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CRRT	within 12 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CRRT	within 24 hours

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Anticipated): September 25, 2018
• Study Completion (Anticipated): September 25, 2018

Study Registration Dates

• First Submitted: September 23, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Sepsis; Shock, Septic; Shock; Acute Kidney Injury
• Other Study ID Numbers: ILBS-CRRT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No