Skip to main content
. 2022 Nov 23;2022(11):CD010612. doi: 10.1002/14651858.CD010612.pub3

Maiwall 2018.

Study name Early versus late sustained low efficiency dialysis in critically ill cirrhotics with septic shock and acute kidney injury: a pilot randomised controlled trial
Methods
  • Study design: parallel, open‐label RCT

  • Duration of study: start July 2018

  • Duration of follow‐up: until day 28 after randomisation

Participants
  • Country: India

  • Health status: cirrhosis with septic shock associated AKI stage 3 AKIN/KDIGO stage 2

  • aged 18 to 65 years

  • Exclusion criteria: < 18 years; severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD); pregnancy; CKD on HD; post renal obstructive AKI; AKI suspected due to GN, interstitial nephritis or vasculitis based on clinical history and urine analysis; already meeting emergency criteria for immediate HD at the time of randomisation (serum potassium > 6 mEq/L, metabolic acidosis pH < 7.12, acute pulmonary oedema, severe volume overload with hypoxaemia non‐responsive to diuretic treatment); transferred from other hospitals who have already been on HD before their arrival in the ICU; extremely moribund patients with an expected life expectancy < 24 hours; failure to get informed consent from family members; haemodynamic instability requiring very high dose of vasopressors

Interventions KRT modality
  • SLED


Intervention group
  • Early SLED within 6 to 12 hours after randomisation


Control group
  • Late SLED when absolute indications will meet

Outcomes Primary outcome
  • Transplant‐free survival in both groups at day 28


Secondary outcomes
  • Death related to kidney failure in both groups at day 7

  • Death due to kidney failure related in both groups at day 7

  • Incidence of intra‐dialytic hypotension in both groups at 48 hours

  • Haemodynamic stability in both groups at 48 hours

  • Dialysis efficiency as measured by URR in both groups at 48 hours

  • Achievement of target ultrafiltration goals in both groups at 48 hours

  • Recovery in kidney function in both groups at day 14

  • Duration of ICU stay in both groups at day 28

  • Duration of mechanical ventilation in both groups at day 28

  • Improvement in SOFA (by 2 points) scores in both groups at day 28

  • Improvement in SOFA, Model for End‐stage Liver Disease (by 2 points) scores at day 28

  • Improvement in Acute Physiology and Chronic Health Evaluation (by 2 points) scores at day 28

  • Improvement in lactic acidosis and lactate clearance at 6 initiations of dialysis in both groups at 6 hours

  • Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups at 12 hours

  • Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups at 24 hours

Starting date 19 October 2016
Contact information rakhi_2011@yahoo.co.in
Notes Last update posted: 7 March 2019
Recruitment status was: recruiting