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

Not Applicable

• Conditions: Cirrhotics With Septic Shock and Acute Kidney Injury
• Interventions: Biological: Late SLED; Biological: Early SLED

• Registration Number: NCT02937961
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Study Start: 2017-12-01
• Status Verified: 2019-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late SLED	Late SLED	-
Early SLED	Early SLED	-

Primary Outcome Measures

Name	Time	Method
Transplant free survival in both groups	28 days

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stability in both groups	48 hours
Achievement of target ultrafiltration goals in both groups	48 hours
Recovery in renal functions in both groups	14 days	Recovery is defined as an increase in urine output to more than 400 ml/day
Duration of Intensive Care Unit stay in both groups	28 days
Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups	28 days
Death related with renal failure in both groups	7 day
Mortality due to renal failure related in both groups.	7 day
Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores	28 days
Incidence of intradialytic hypotension in both groups	48 hours
Duration of mechanical ventilation in both groups	28 days
Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores	28 days
Dialysis efficiency as measured by Urea Reduction ratio in both groups	2 days
Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups	6 hours
Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups	24 hours

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India