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| ID | Type | Description | Link |
|---|---|---|---|
| DT.007/24 | Other Grant/Funding Number | Vietnam Ministry of Health |
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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
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
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Age from 1 month to <18 years
Diagnosis of septic shock according to Phoenix Sepsis Criteria, defined as:
Fulfillment of at least one of the following:
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
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
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Pediatric patients with septic shock admitted to the PICU and receiving early continuous renal replacement therapy as part of routine clinical care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Children's Hospital | Hanoi | Vietnam |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2025 | Jan 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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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 |
| up to Day 28 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |