Randomized Control Study in REsuscitation of SEpsis Trial

Launched by FUNDACIÓN CARDIOINFANTIL INSTITUTO DE CARDIOLOGÍA · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial, called the REsuscitation of SEpsis Trial (RESET), is studying the best type of fluid to give children with sepsis—a serious infection that can affect how well their organs work. The trial compares three fluids used to help children recover: normal saline (a saltwater solution), Ringer’s lactate (a fluid with salts and minerals), and Octaplas LG, a specially processed plasma product that contains important proteins and is carefully sterilized to reduce infection risk. Researchers want to see if Octaplas LG works better or is as safe as the other fluids in helping children recover from sepsis.

Children between 1 month and 18 years old who are in the pediatric intensive care unit with sepsis and need fluids to support their heart and blood flow may be eligible. If your child joins the study, they will be randomly assigned to receive one of the three fluids alongside standard sepsis treatments like antibiotics and monitoring. They will stay in the study for up to 28 days or until they no longer need intensive care. Participation is voluntary, and choosing not to join will not affect your child’s medical care. This study aims to include about 150 children and could help doctors find better ways to treat sepsis in young patients.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Age: ≥1 month (corrected gestational age) to 18 years.
• * Diagnosis of sepsis with at least one of the following conditions:
• • Signs of poor perfusion: prolonged capillary refill ≥2 sec, weak peripheral pulses, unexplained metabolic acidosis (base deficit \> (-)5.0 mEq/L), altered. mental status, lactate ≥2 mmol/L (sample drawn without tourniquet use. (Appendix 2). OR
• • Systolic blood pressure (SBP) below the 5th percentile for age.
• • Signed informed consent from the patient's legal guardian.
• Exclusion Criteria:
• • Receipt of ≥2 boluses of NS 0.9% or balanced solution in the last 24 hours for the current sepsis episode (bolus defined as ≥10 mL/kg (max. 500 mL) of NS/RL given in \<30 min).
• • Known allergic reaction to plasma-derived products.
• • Known IgA deficiency.
• • Suspected or confirmed congestive heart failure.
• • Nephrotic syndrome.
• • Known chronic kidney disease with fluid overload or congestive heart failure.
• • Diagnosed hemorrhagic dengue fever confirmed by antigen or serology (NS1 or IgM positive).