NCT02937961

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

Status unknown NA Last updated 7 March 2019

What this trial tests

NA trial testing Early SLED in Cirrhotics With Septic Shock and Acute Kidney Injury in 150 participants. Status unknown.

Timeline

1 December 2017

Primary endpoint
1 March 2019

1 March 2019

Quick facts

Lead sponsor	Institute of Liver and Biliary Sciences, India
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 December 2017
Primary completion	1 March 2019
Estimated completion	1 March 2019
Sites	1 location across India

Drugs / interventions tested

• Early SLED — full drug profile →
• Late SLED — full drug profile →

Conditions studied

• Cirrhotics With Septic Shock and Acute Kidney Injury — all drugs for Cirrhotics With Septic Shock and Acute Kidney Injury →

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

18 and older, any sex, with Cirrhotics With Septic Shock and Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perioperative Acute Kidney Injury.
   Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968
2. ESICM LIVES 2021: Part 1.
   · 2021 · cited 6× · PMID 34633565 · DOI 10.1186/s40635-021-00413-8
3. Early Versus Late Dialysis in Cirrhosis Patients and Septic Shock (ELDICS Study): A Randomized Controlled Trial (NCT02937961).
   Maiwall R, Pasupuleti SSR, Agarwal P, Thomas S, et al · · 2025 · PMID 41020192 · DOI 10.1002/jgh3.70216