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Comparison of utility of Lactated Ringers versus Normal saline in initial treatment of shock due to infection in children

Lactated Ringers versus Normal Saline in initial fluid resuscitation in Children with septic shock - A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048504
Enrollment
40
Registered
2022-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: ringers lactate bolus: To study the efficacy of Ringer�s lactate in fluid resuscitation as bolus fluid of 20ml/kg during the acute management of septic shock compared to Normal S

Sponsors

Christian Medical College and Hospital Ludhiana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Fulfilling criteria for sepsis and septic shock as per International Pediatric Sepsis Consensus Conference -2005 1.Suspected or proven infection caused by any pathogen or clinical syndrome with high probability of infection, associated with 2.Presence of at least two of the following clinical manifestations (requiring abnormal temperature or white blood cell count): 1.Temperature >38.5 ââ??¦C or 2.Tachycardia or bradycardia (values adjusted to age) 3.Tachypnea (according to the age range) unrelated to neuromuscular disease or anesthesia. 4.Elevated or suppressed leukocyte count according to values for each age group. 3.Septic shock: patient with sepsis with acute circulatory failure, persistent hypotension 1. Hypotension or 2. Reliance on vasoactive drug administration to maintain a normal blood pressure or 3. Two or more of the following signs of inadequate tissue perfusion -prolonged capillary refill, oliguria, metabolic acidosis, elevated blood lactate

Exclusion criteria

Exclusion criteria: 1.Consent refused by parents/guardian 2.Post cardiac arrest shock 3.Cardiogenic shock 4.Neurogenic shock 5.Burns, Road Traffic accident 6.Hypovolemic shock (dehydration, blood loss) 7.Pre-existing hepato-renal disease 8.Known inborn errors of metabolism 9.Death or DAMA within 24 hours of hospitalisation 10.Patients included in other studies on septic shock

Design outcomes

Primary

MeasureTime frame
Time taken and total volume of fluid required as per weight for reversal of shockTimepoint: every one hourly till shock reversal is achieved

Secondary

MeasureTime frame
To assess safety profile of Ringers Lactate versus Normal saline ( allergic reaction, electrolyte imbalance, acid base disorder)Timepoint: Serum electrolyte every twelve hourly Arterial blood gas analysis with Lactate estimation every six hourly;2.Treatment outcomes of children with septic shock treated with RL versus NSTimepoint: EVERY 1 TO 6 HOURLY TILL DISCHARGE

Countries

India

Contacts

Public ContactBeninsujalini B

Christian Medical College, Ludhiana

monika.sharma@cmcludhiana.in9814861205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026