NCT03343340

Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI

Status unknown NA Last updated 17 November 2017

What this trial tests

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

Timeline

25 September 2017

Primary endpoint
25 September 2018

25 September 2018

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	25 September 2017
Primary completion	25 September 2018
Estimated completion	25 September 2018
Sites	1 location across India

Drugs / interventions tested

• Early CRRT
• Late CRRT
• Standard Medical Therapy — full drug profile →

Conditions studied

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

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

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

Sponsor's own description

Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. 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, 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. Timing of kidney replacement therapy initiation for acute kidney injury.
   Fayad AI, Buamscha DG, Ciapponi A. · · 2022 · cited 15× · PMID 36416787 · DOI 10.1002/14651858.cd010612.pub3
3. ESICM LIVES 2023.
   · 2023 · cited 2× · PMID 37874422 · DOI 10.1186/s40635-023-00546-y