NCT04494542

Brief Summary

The current prospective pliot randomized controlled trial has been designed to demonstrate non-inferiority of sustained low efficiency dialysis (SLED) when compared to continuous renal replacement therapy in managing AKI in context of cirrhotics with septic shock who are hemodynamically unstable. The patients would be randomized 1:1 to either SLED or CRRT after screening for the inclusion and exclusion criteria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

July 28, 2020

Last Update Submit

November 2, 2023

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Development of intradialytic hypotension i.e. decrease in defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by 10 mm Hg after initiation of dialysis

    at 6 hours after dialysis initiation

Secondary Outcomes (7)

  • Mortality in both groups

    Day 28

  • Duration of mechanical ventilation and ICU stay

    Day 28

  • AKI recovery at day 14

    Day 14

  • Renal failure related death at day 7

    Day 7

  • Lactate clearance at 12 in both groups

    12 hours

  • +2 more secondary outcomes

Study Arms (2)

Sustained Low Efficiency Dialysis

EXPERIMENTAL

Sustained Low Efficiency Dialysis

Procedure: Sustained Low Efficiency Dialysis (SLED)

Continuous Renal Replacement Therapy

ACTIVE COMPARATOR

continuous renal replacement therapy

Procedure: Continuous Renal Replacement Therapy

Interventions

Sustained Low Efficiency Dialysis (SLED)PROCEDURE

sustained low efficiency dialysis (SLED)

Sustained Low Efficiency Dialysis
Continuous Renal Replacement TherapyPROCEDURE

Continuous Renal Replacement Therapy

Continuous Renal Replacement Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Critically ill cirrhotics with septic shock defined as need of vasopressors to maintain MAP\> 65 mm Hg and lacate \>2 mmol/L despite adequate fluid resuscitation with severe AKI meeting criteria for dialysis

You may not qualify if:

  • Patients with age less than 18 years or more than 65 years
  • Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD, CKD)
  • Patients with ACLF
  • Patients with cerebral edema
  • Patients with refractory shock i.e. requiring norepinephrine or equivalent \>0.5ug/kg/min
  • Severe coagulopathy platelets \<20,000 and INR \>4
  • Active Bleed (Mucosal or variceal)
  • Pregnancy
  • Patients with moderate-severe ARDS i.e. Pa02/Fio2 ratio \<200
  • Extremely moribund patients with an expected life expectancy of less than 24 hours
  • Failure to give informed consent from family members.
  • Patient enrolled in other clinical trials
  • Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
  • Patients who have already been on hemodialysis before their arrival in the intensive care unit
  • Patients with severe vasodilatation SVR \<400 dyn·s/cm5 and/or lactate \> 5 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Hybrid Renal Replacement TherapyContinuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

October 16, 2020

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

Locations

IN(1)