Balanced salt solutions versus saline

Comparison of Acetate-based, Lactate-based and Multiple Electrolyte Solution versus saline (MeSLAc trial) in pediatric septic shock – A multicenter randomized controlled trial - MesLAC

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045580

Enrollment

408

Registered

2022-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I958- Other hypotension

Interventions

Intervention1: Ringers lactate: Ringers lactate fluid will be given as boluses of 10-20 ml/kg each for 7 days Intervention2: Ringers Acetate: Ringers acetate fluid will be used as bolus in volumes of

Eligibility

Inclusion criteria

Inclusion criteria: Children 2 month to = 17 years with features of septic shock –defined as children who have a suspected infection and have at least two clinical signs of decreased perfusion with or without hypotension.

Exclusion criteria

Exclusion criteria: 1. Children receiving fluid boluses before enrollment 2. Children with cardiogenic shock 3. Known patient with chronic kidney disease with baseline deranged renal function (eGFR 4. Severe malnutrition 5. Children whose parents refuse to give an informed consent

Design outcomes

Primary

Measure	Time frame
To examine if use of any one of these balanced crystalloids - Ringers lactate, Ringers acetate or Plasmalyte A is superior to Saline in terms of lower incidence of composite end point of MAKE30 measured at day 30 ( Major Adverse Kidney events include- new onset or progressive AKI, in-hospital mortality, new renal replacement therapy, or persistent renal dysfunction at 30 days ) after initial fluid resuscitation.Timepoint: Till 30 days of fluid resuscitation	—

Measure

Time frame

To examine if use of any one of these balanced crystalloids - Ringers lactate, Ringers acetate or Plasmalyte A is superior to Saline in terms of lower incidence of composite end point of MAKE30 measured at day 30 ( Major Adverse Kidney events include- new onset or progressive AKI, in-hospital mortality, new renal replacement therapy, or persistent renal dysfunction at 30 days ) after initial fluid resuscitation.Timepoint: Till 30 days of fluid resuscitation

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Secondary

Measure	Time frame
a) Incidence of hyperchloremia & metabolic acidosis at 6 & 24 hours b) Requirement of fluid boluses in first 6 hours & total fluids in first 24 hours, 48 hours & 72 hours. c) Proportion of patients achieving the pre-determined therapeutic end points at 6 hours after intervention. Time to achievement of therapeutic goals. d)In-ICU mortality rates Timepoint: Hyperchloremia assessed at 6, 24, 48, 72 hours & 7 days Total fluids received as boluses in first 6 hours & total fluids in 24 hours, 48 hours & 72 hours. Proportion of patients achieving therapeutic end points & time taken for resolution of shock. Mortality during ICU stay	—

Measure

Time frame

a) Incidence of hyperchloremia & metabolic acidosis at 6 & 24 hours b) Requirement of fluid boluses in first 6 hours & total fluids in first 24 hours, 48 hours & 72 hours. c) Proportion of patients achieving the pre-determined therapeutic end points at 6 hours after intervention. Time to achievement of therapeutic goals. d)In-ICU mortality rates Timepoint: Hyperchloremia assessed at 6, 24, 48, 72 hours & 7 days Total fluids received as boluses in first 6 hours & total fluids in 24 hours, 48 hours & 72 hours. Proportion of patients achieving therapeutic end points & time taken for resolution of shock. Mortality during ICU stay

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Countries

India

Contacts

Public ContactJhuma Sankar

AIIMS

jhumaji@gmail.com09818399864

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026