Balanced Crystalloid vs. Saline in Children With Septic Shock

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.

Conditions

• Septic Shock
• Shock

Interventions

DRUG

Balanced crystalloid solution

Multiple electrolyte solution as boluses would be administered.

DRUG

0.9%sodium chloride

saline as boluses would be administered

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• Jawaharlal Institute of Postgraduate Medical Education & Research

  collaborator OTHER_GOV

• St Johns Medical College Hospital, Bangalore, India

  collaborator OTHER

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Jhuma Sankar, MD Ped · All India Institute of Medical Sciences

• Sushil K Kabra, MD Ped · All India Institute of Medical Sciences

• Rakesh Lodha, MD Ped · All India Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-01

Primary Completion

2020-01-15

Completion

2020-01-15

Countries

• India

Study Locations