Balanced Crystalloid vs. Saline in Children With Septic Shock
Status:
Completed
Trial end date:
2020-01-15
Target enrollment:
Participant gender:
Summary
Fluid resuscitation is the cornerstone of pediatric shock management; current practices of
fluid resuscitation in children are not evidence based. Normal saline is the preferred
crystalloid recommended during initial resuscitation in shock, as the incidence of
hyponatremia is lower with normal saline compared to all other fluids available and commonly
used. However, normal saline has its own set of undesired physicochemical actions. Emerging
data strongly indicate the increased incidence of hyperchloremia, metabolic acidosis and
consequently, acute kidney injury associated with infusion of large volumes of normal saline.
Balanced salt solutions or crystalloids, which have composition resembling plasma but lower
chloride concentrations than normal saline, clearly decrease the risk of hyperchloremia and
metabolic acidosis in adult as well as pediatric studies when used during the peri-operative
period. The results favored balanced solutions in comparison to normal saline. Recent
systematic reviews comparing balanced or buffered versus non-buffered fluids for surgery in
adults favored the former solution as the metabolic derangements were less with the use of
this type of fluid. In adult patients, the two solutions have been compared in various other
settings as well such as in traumatic brain injury and in shock. The results favored balanced
solutions in comparison to normal saline. However, in the non-surgical setting there is a
paucity of evidence on the use of these solutions in children with shock and more evidence
needs to be generated to support or refute the use of this fluid as compared to normal
saline.
Given this background, the investigators decided to compare the effect of two solutions on
the incidence of acute kidney injury in children resuscitated with either of the two fluids.
Children receiving at least one fluid bolus at 20 ml/kg in the first hour would be enrolled
and followed up for the proposed outcome variables. The investigators plan to enroll 708
patients over a period of 3 years. The investigators believe that the proposed study will
provide answer to the research question of which of the fluids could be preferred for
resuscitation.
Phase:
N/A
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi
Collaborators:
Jawaharlal Institute of Postgraduate Medical Education & Research Postgraduate Institute of Medical Education and Research