Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI
Primary Purpose
Septic Shock and Acute Kidney Injury
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Early CRRT
Late CRRT
Standard Medical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock and Acute Kidney Injury
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
Sites / Locations
- Institute of Liver and Biliary SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early CRRT
Late CRRT
Arm Description
Early Continous Renal Replacement Therapy within 6 hours + Standard Medical Therapy
Late Continous Renal Replacement Therapy + Standard Medical Therapy
Outcomes
Primary Outcome Measures
Transplant Free Survival
Secondary Outcome Measures
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
Hemodynamic stability i.e. maintenance of MAP on dialysis without increase in the vasopressors
Dialysis efficiency as measured by Urea Reduction ratio at 48 hours
Achievement of target ultrafiltration goals
Recovery in renal functions defined as an increase in urine output to more than 400 ml/day
Duration of mechanical ventilation and ICU (Intensive Care Unit) stay
Improvement in SOFA (Sequential Organ Failure Assessment ) ( by 2 points) scores
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) ( by 2 points) scores
Improvement in MELD (Model for End Stage Liver Disease) ( by 2 points) scores
Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CRRT
Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CRRT
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CRRT
Full Information
NCT ID
NCT03343340
First Posted
September 23, 2017
Last Updated
November 9, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03343340
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
September 25, 2018 (Anticipated)
Study Completion Date
September 25, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock and Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early CRRT
Arm Type
Experimental
Arm Description
Early Continous Renal Replacement Therapy within 6 hours + Standard Medical Therapy
Arm Title
Late CRRT
Arm Type
Active Comparator
Arm Description
Late Continous Renal Replacement Therapy + Standard Medical Therapy
Intervention Type
Other
Intervention Name(s)
Early CRRT
Intervention Description
Continous Renal Replacement Therapy
Intervention Type
Other
Intervention Name(s)
Late CRRT
Intervention Description
Continous Renal Replacement Therapy
Intervention Type
Other
Intervention Name(s)
Standard Medical Therapy
Intervention Description
Standard Medical Therapy
Primary Outcome Measure Information:
Title
Transplant Free Survival
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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
Time Frame
1 year
Title
Hemodynamic stability i.e. maintenance of MAP on dialysis without increase in the vasopressors
Time Frame
1 year
Title
Dialysis efficiency as measured by Urea Reduction ratio at 48 hours
Time Frame
2 days
Title
Achievement of target ultrafiltration goals
Time Frame
1 year
Title
Recovery in renal functions defined as an increase in urine output to more than 400 ml/day
Time Frame
1 year
Title
Duration of mechanical ventilation and ICU (Intensive Care Unit) stay
Time Frame
1 year
Title
Improvement in SOFA (Sequential Organ Failure Assessment ) ( by 2 points) scores
Time Frame
1 year
Title
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) ( by 2 points) scores
Time Frame
1 year
Title
Improvement in MELD (Model for End Stage Liver Disease) ( by 2 points) scores
Time Frame
1 year
Title
Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CRRT
Time Frame
within 6 hours
Title
Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CRRT
Time Frame
within 12 hours
Title
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CRRT
Time Frame
within 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Rakhi Maiwall, MD,DM
Phone
01146300000
Email
rakhi_2011@yahoo.co.in
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI
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