Early Continuous Renal Replacement Therapy for Pediatric Septic Shock

NCT07370753 | Active Not Recruiting

• 2 other identifiers: IRB-VN01037/IRB00011976/FWA000DT.007/24
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome; Septic Shock

Keywords

pediatric sepsis; septic shock; multiple organ dysfunction syndrome; cytokines

Outcome Measures

Primary Outcomes (2)

• Time to shock reversal

  Shock reversal is defined as sustained improvement in hemodynamic stability, including reduction of vasoactive support, normalization of age-adjusted heart rate and blood pressure, arterial lactate \<2 mmol/L, and central venous oxygen saturation (ScvO₂) between 70-75%.

  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

  Change in organ dysfunction severity assessed using the Pediatric Sequential Organ Failure Assessment (pSOFA) score (range: 0-24), with higher scores indicating more severe organ dysfunction

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

Secondary Outcomes (4)

• Change in mean arterial pressure (MAP)

  Time Frame: Baseline, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after CRRT initiation

• Change in serum cytokine levels

  Baseline, 12 hours, 24 hours, and 48 hours after CRRT initiation

• Changes in serum lactate concentration

  Baseline, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after CRRT initiation

• Mortality outcomes

  up to day 28

Other Outcomes (1)

• ICU resource utilization

  up to Day 28

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with septic shock admitted to the PICU and receiving early continuous renal replacement therapy as part of routine clinical care

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead

Study Sites (1)

Vietnam National Children's Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 27, 2026
• Study Start: May 20, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): March 18, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)