SLED (procedure) versus CRRT (procedure) in Liver disease with kidney injury

Not Applicable

• Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2020/09/027528
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

1.Patients with age less than 18 years or more than 65 years

2.Severe known cardiopulmonary disease (structural or valvular heart

disease, coronary artery disease, COPD, CKD)

3.Patients with ACLF

4.Patients with cerebral edema

5.Patients with refractory shock i.e. requiring norepinephrine or equivalent

>0.5ug/kg/min

6.Severe coagulopathy platelets <20,000 and INR >4

7.Active Bleed (Mucosal or variceal)

8.Pregnancy

9.Patients with moderate-severe ARDS i.e. Pa02/Fio2 ratio <200

10.Extremely moribund patients with an expected life expectancy of less

than 24 hours

11.Failure to give informed consent from family members.

12.Patient enrolled in other clinical trials

13.Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis

14.Patients who have already been on hemodialysis before their arrival in

the intensive care unit

15.Patients with severe vasodilatation SVR <400 dyn·s/cm5 and/or lactate

> 5 mmol/L

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of intradialytic hypotension i.e. decrease in defined as a decrease in systolic blood pressure by â?¥20 mm Hg or a decrease in MAP by 10 mm Hg after initiation of dialysisTimepoint: at 6 hours after dialysis initiation

Secondary Outcome Measures

Name	Time	Method
AKI recovery at day 14Timepoint: Day 14;Duration of mechanical ventilation and ICU stayTimepoint: Day 28;Lactate clearance at 12 hrs and 24 hoursTimepoint: 12 hrs and 24 hours;MortalityTimepoint: 28 days;Renal failure related death at day 7Timepoint: Day 7;Reversal of shock at 48 hoursTimepoint: 48 hours