NCT07035509View on ClinicalTrials.gov

Randomized Control Study in REsuscitation of SEpsis Trial

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 15, 2026

Study Completion Date

July 15, 2026

Conditions
Septic ShockPediatric Critical Illness
Interventions
BIOLOGICAL

Pharmaceutical fresh frozen plasma

OCTAPLAS LG® has been registered with INVIMA in Colombia for five years and is used as a plasma replacement in cardiac surgery, hematologic diseases, or intensive care settings where blood bank plasma is unavailable

DRUG

Normal Saline

Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over \<15 minutes.

DRUG

Ringer lactate (RL)

Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over \<15 minutes.

Trial Locations (1)

111031

Fundacion CardioInfantil - Instituto de Cardiología, Bogotá

All Listed Sponsors
collaborator

University of Pittsburgh

OTHER

lead

Fundación Cardioinfantil Instituto de Cardiología

OTHER