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Comparision of two fluids in the management of sepsis in children

Randomized Control Study on Normal Saline vs Plasma in REsuscitation of SEpsis Trial (RESET) â?? A Feasibility and Comparative Study - RESET

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025693
Enrollment
100
Registered
2020-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B95-B97- Bacterial and viral infectious agents

Interventions

Intervention1: Fresh Frozen Plasma: Fresh Frozen Plasma 10ml/kg bolus dosing (max 500 ml) over less than 15 min Control Intervention1: Normal Saline: Normal Saline 10ml/kg bolus dosing (max 500 ml) ov

Sponsors

Arun Bansal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 1 month (Corrected gestational age) to completed 12 years 2. Suspected Sepsis with the following: 2.1. Signs of poor perfusion: Prolonged CFT > 5 sec, poor peripheral pulses, unexplained metabolic acidosis: base deficit > 5.0 mEq/L, altered mental status, Lactate > or 2x upper limit of normal OR 2.2. SBP 3. Informed written consent

Exclusion criteria

Exclusion criteria: 1. Have received 2 or more NS boluses in the last 24 hours for current episode of sepsis. Bolus is defined as at least 10ml/kg (max 500 ml) of NS/RL given over less than 30 min. 2. Known allergic reaction to plasma products 3. Known IgA deficiency 4. Suspected/known congestive heart failure 5. Nephrotic Syndrome 6.Known chronic kidney disease with fluid overload or congestive heart failure 7. Diagnosed Dengue fever (NS1 or IgM Positive) 8. If previously enrolled and discharged from PICU. 9. Consent not given

Design outcomes

Primary

MeasureTime frame
To study the feasibility of using normal saline v/s fresh frozen plasma as the initial resuscitation fluid in pediatric septic shockTimepoint: 48 Hours—

Secondary

MeasureTime frame
1. Intravascular volume by echocardiography at 6 ± 2, 24 ± 8 and 48 ± 8 hours in the 2 groups. 2. Total amount of saline or plasma given for resuscitation in the first 6, 24 and 48 hours. 3. Net fluid balance at 24 and 48 hours. 4. Organ dysfunction score by PeLOD, pSOFA and NPMODS daily for 48 hours 5. Endothelial injury markers and hemostasis parameters 6. Inflammatory markers and coagulation activation measures 7. Transfusion related reactions 8. To compare the 28-day mortality Timepoint: 48 hours—

Countries

India

Contacts

Public ContactArun Bansal

PGIMER

drarunbansal@gmail.com9815455002

Outcome results

None listed

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