Early Continuous Renal Replacement Therapy for Pediatric Septic Shock

Early Application of Continuous Renal Replacement Therapy as Adjunctive Support in Pediatric Septic Shock: A Prospective Observational Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Septic Shock; Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome

Detailed Description

This is a prospective observational cohort study conducted in pediatric intensive care units (PICUs). Children diagnosed with septic shock who receive early continuous renal replacement therapy (CRRT) as part of routine clinical care will be consecutively enrolled.

Baseline assessments will be performed prior to CRRT initiation and include clinical status, hemodynamic parameters, echocardiographic indices, laboratory markers, and inflammatory cytokine levels. Follow-up assessments will be conducted at predefined time points after CRRT initiation.

CRRT initiation, modality, and management will follow institutional protocols and treating physician judgment. No randomization or intervention assignment is performed. Patients will be followed during PICU stay and up to Day 28 after PICU admission

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Vietnam National Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean arterial pressure (MAP)	Change in mean arterial pressure measured after initiation of continuous renal replacement therapy (CRRT), unit of measurement is mmHg	Time Frame: Baseline, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after CRRT initiation
Change in serum cytokine levels	Change in serum cytokine concentrations, including tumor necrosis factor alpha (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-12 (IL-12), interferon gamma (IFN-γ), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), and interleukin-4 (IL-4), measured after initiation of continuous renal replacement therapy (CRRT). All cytokines will be measured using the same assay platform and reported in the same unit of concentration. Unit of measurement is pg/ml	Baseline, 12 hours, 24 hours, and 48 hours after CRRT initiation
Changes in serum lactate concentration	Change in serum lactate concentration measured after initiation of continuous renal replacement therapy (CRRT). Unit of measurement is mmol/L	Baseline, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after CRRT initiation
Mortality outcomes	All-cause mortality at Day 7 All-cause mortality at Day 28	up to day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU resource utilization	ICU-free days: calculated as 28 minus ICU length of stay for patients discharged alive before Day 28; assigned 0 for patients who die before Day 28 or remain in ICU on/after Day 28. Ventilator-free days: calculated as 28 minus days of invasive mechanical ventilation for patients alive and ventilated <28 days; assigned 0 for patients who die before Day 28 or remain ventilated on/after Day 28. Vasopressor-free days: calculated as 28 minus days receiving vasoactive agents for patients alive and requiring vasoactives <28 days; assigned 0 for patients who die before Day 28 or remain on vasoactives on/after Day 28. Discontinuation requires ≥12 hours without vasoactive support	up to Day 28

Collaborators and Investigators

• Sponsor: National Children's Hospital, Vietnam

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): March 18, 2028

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; cytokines; multiple organ dysfunction syndrome; pediatric sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic; Multiple Organ Failure
• Other Study ID Numbers: IRB-VN01037/IRB00011976/FWA000; DT.007/24 (Other Grant/Funding Number: Vietnam Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No