Early Continuous Renal Replacement Therapy for Pediatric Septic Shock (NCT07370753) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Continuous Renal Replacement Therapy for Pediatric Septic Shock
Vietnam50 participantsStarted 2025-05-20
Plain-language 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
Who can participate
Age range
1 Month – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to shock reversal
Timeframe: From initiation of CRRT until first documented shock reversal, assessed up to 7 days after CRRT initiation during PICU stay
2
Change in Pediatric Sequential Organ Failure Assessment (pSOFA) Score
Timeframe: Baseline, 24 hours, 48 hours, 72 hours, Day 5, and Day 7 after CRRT initiation