Life Sciences & Biotechnology
Title : | Comparison of Acetate-based, Lactate-based and Multiple Electrolyte Solution versus saline (MeSLAc trial) in pediatric septic shock – A multicenter randomized controlled trial |
Area of research : | Life Sciences & Biotechnology |
Principal Investigator : | Dr. Jhuma Sankar, All India Institute Of Medical Sciences (AIIMS), New Delhi |
Timeline Start Year : | 2023 |
Timeline End Year : | 2026 |
Contact info : | jhumasankar@gmail.com |
Details
Executive Summary : | Fluid resuscitation is an important step in the early management of septic shock which has a high mortality rate ( upto 50%) in children. Crystalloid solutions are recommended for initial fluid resuscitation; saline (0.9% sodium chloride) is commonly used, as it is inexpensive and readily available with an efficacy similar to colloids with respect to shock resolution and mortality. Balanced crystalloids (BC) have a composition resembling plasma. Some BCs (e.g., multiple electrolytes solution (MES) or Plasma-Lyte A) have been reported to be associated with decreased risk of metabolic disturbances such as hyperchloremia and acidosis as compared to saline in patients from diverse patient settings. In a previous study by our group of 708 children, we observed lower risk of new or progressive AKI in the first 7 days after fluid resuscitation with the use of MES as compared to saline in children with septic shock. With this study we gained experience in conducting multicentre RCT addressing fluid resuscitation in children. However, in this study we compared only one type of BC with saline i.e. MES. The cost of MES is twice that of saline while that of Ringers lactate (RL) is similar to that of saline. Not only the cost, there are important differences between the different types of crystalloids available. There are no studies comparing Ringers Acetate (RA) and Ringers Lactate (RL) amongst each other or with MES on metabolic parameters or AKI in children. The limited data available comparing these solutions in adults have found RA to have the advantage of extrahepatic metabolism with less oxygen demand compared to RL which is heavily dependent on liver for its metabolism. Using solutions in large volumes and/or rapid speed as is used in resuscitation may cause added burden on the already compromised liver and worsen its functions. Multiorgan dysfunction carries high mortality and morbidity in children with septic shock. Finally, most studies comparing BCs have evaluated the metabolic abnormalities resulting from their infusion and there is a dearth of information on the impact of using various BCs on patient-important outcomes such as mortality, hospital length of stay, and receipt or duration of life support. The Pediatric Surviving Sepsis Campaign (SSC) recently issued a recommendation to use balanced crystalloids, rather than saline, for the initial resuscitation in septic shock. This suggestion, however, was based on evidence of limited quality, prompting the SSC committee to comment in their report that the ‘type of fluid’ to be used for resuscitation should be a research priority. Thus the knowledge gaps with regard to initial fluid resuscitation identified and requiring answers in management of pediatric septic shock are – a) Which is the ideal crystalloid for initial resuscitation in children with septic shock ? and b) Which is a better balanced crystalloid of the 3 buffered salt solutions available readily and affordable – RL; RA and MES. |
Total Budget (INR): | 29,46,196 |
Organizations involved