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Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury

Primary Purpose

Cirrhotics With Septic Shock and Acute Kidney Injury

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Early SLED
Late SLED
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhotics With Septic Shock and Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver and Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early SLED

Late SLED

Arm Description

Outcomes

Primary Outcome Measures

Transplant free survival in both groups

Secondary Outcome Measures

Incidence of intradialytic hypotension in both groups
Hemodynamic stability in both groups
Dialysis efficiency as measured by Urea Reduction ratio in both groups
Achievement of target ultrafiltration goals in both groups
Recovery in renal functions in both groups
Recovery is defined as an increase in urine output to more than 400 ml/day
Duration of Intensive Care Unit stay in both groups
Duration of mechanical ventilation in both groups
Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups
Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores
Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores
Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Death related with renal failure in both groups
Mortality due to renal failure related in both groups.

Full Information

First Posted
October 17, 2016
Last Updated
March 4, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02937961
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhotics With 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 SLED
Arm Type
Experimental
Arm Title
Late SLED
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Early SLED
Intervention Description
withing 6 to 12 hours
Intervention Type
Biological
Intervention Name(s)
Late SLED
Intervention Description
when absolute indications will meet
Primary Outcome Measure Information:
Title
Transplant free survival in both groups
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of intradialytic hypotension in both groups
Time Frame
48 hours
Title
Hemodynamic stability in both groups
Time Frame
48 hours
Title
Dialysis efficiency as measured by Urea Reduction ratio in both groups
Time Frame
2 days
Title
Achievement of target ultrafiltration goals in both groups
Time Frame
48 hours
Title
Recovery in renal functions in both groups
Description
Recovery is defined as an increase in urine output to more than 400 ml/day
Time Frame
14 days
Title
Duration of Intensive Care Unit stay in both groups
Time Frame
28 days
Title
Duration of mechanical ventilation in both groups
Time Frame
28 days
Title
Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups
Time Frame
28 days
Title
Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores
Time Frame
28 days
Title
Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores
Time Frame
28 days
Title
Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups
Time Frame
6 hours
Title
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Time Frame
12 hours
Title
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups
Time Frame
24 hours
Title
Death related with renal failure in both groups
Time Frame
7 day
Title
Mortality due to renal failure related in both groups.
Time Frame
7 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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

Plan to Share IPD
No

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Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury

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