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Active, Not Recruiting

NCT Number: NCT07370753

Early Continuous Renal Replacement Therapy for Pediatric Septic Shock

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome Infections Inflammation Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vietnam National Children's Hospital

Hanoi, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to shock reversal

    Time frame: 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%.

  2. Change in Pediatric Sequential Organ Failure Assessment (pSOFA) Score

    Time frame: 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 outcomes

  1. Change in mean arterial pressure (MAP)

    Time frame: 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

  2. Change in serum cytokine levels

    Time frame: 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

  3. Changes in serum lactate concentration

    Time frame: 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

  4. Mortality outcomes

    Time frame: up to day 28

    All-cause mortality at Day 7 All-cause mortality at Day 28

Other outcomes

  1. ICU resource utilization

    Time frame: up to Day 28

    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

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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