Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome, Septic Shock
Conditions
Keywords
pediatric sepsis, septic shock, multiple organ dysfunction syndrome, cytokines
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
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
Interventions
None listed
Sponsors
National Children's Hospital, Vietnam
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to shock reversal | From initiation of CRRT until first documented shock reversal, assessed up to 7 days after CRRT initiation during PICU stay | 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%. |
| Change in Pediatric Sequential Organ Failure Assessment (pSOFA) Score | Baseline, 24 hours, 48 hours, 72 hours, Day 5, and Day 7 after CRRT initiation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 mean arterial pressure measured after initiation of continuous renal replacement therapy (CRRT), unit of measurement is mmHg |
| Change in serum cytokine levels | Baseline, 12 hours, 24 hours, and 48 hours after CRRT initiation | 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 |
| Changes in serum lactate concentration | Baseline, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after CRRT initiation | Change in serum lactate concentration measured after initiation of continuous renal replacement therapy (CRRT). Unit of measurement is mmol/L |
| Mortality outcomes | up to day 28 | All-cause mortality at Day 7 All-cause mortality at Day 28 |
Countries
Vietnam
Outcome results
None listed