Active — Not RecruitingNot Applicable

Early Continuous Renal Replacement Therapy for Pediatric Septic Shock

Vietnam50 participantsStarted 2025-05-20

Plain-language summary

Septic shock is a major cause of morbidity and mortality in critically ill children. Continuous renal replacement therapy (CRRT) is increasingly used as adjunctive support in pediatric septic shock to improve hemodynamic stability, modulate inflammatory responses, and correct metabolic disturbances. However, evidence regarding optimal indications, timing, and clinical outcomes of early CRRT use in children remains limited. This prospective observational study aims to evaluate associations between early CRRT use and changes in hemodynamics, organ dysfunction, inflammatory cytokine levels, and short-term clinical outcomes in pediatric patients with septic shock admitted to pediatric intensive care units

Who can participate

Age range1 Month – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age from 1 month to \<18 years * Diagnosis of septic shock according to Phoenix Sepsis Criteria, defined as: * Phoenix Sepsis Score ≥ 2, and * Presence of circulatory dysfunction * Fulfillment of at least one of the following: * Acute kidney injury KDIGO stage 2 or higher * Requirement for vasoactive support with Vasoactive-Inotropic Score (VIS) ≥ 50 * Admission to a Pediatric Intensive Care Unit (PICU) * Written informed consent obtained from parent(s) or legal guardian(s) Exclusion Criteria: * Expected survival \<24 hours at time of screening o End-stage organ failure, including: End-stage renal disease requiring chronic dialysis or eGFR \<15 mL/min/1.73 m² * End-stage liver disease * End-stage heart failure * Known immunosuppression, including HIV infection or primary immunodeficiency disorders * Emergency indications for CRRT unrelated to septic shock (e.g., severe hyperkalemia, severe dysnatremia, symptomatic uremia, or fluid overload \>10%) * PICU length of stay \<24 hours * CRRT duration \<6 hours

What they're measuring

Time to shock reversal

Timeframe: From initiation of CRRT until first documented shock reversal, assessed up to 7 days after CRRT initiation during PICU stay

Change in Pediatric Sequential Organ Failure Assessment (pSOFA) Score

Timeframe: Baseline, 24 hours, 48 hours, 72 hours, Day 5, and Day 7 after CRRT initiation

Trial details

NCT IDNCT07370753

SponsorNational Children's Hospital, Vietnam

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-30

View on ClinicalTrials.gov More Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome trials