Pediatric Sepsis-induced Multiple Organ Dysfunction SyndromeNCT07370753
Early Continuous Renal Replacement Therapy for Pediatric Septic Shock
An observational study of Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome and Septic Shock, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome, Septic Shock
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 20 May 2025to 18 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with septic shock admitted to the PICU and receiving early continuous renal replacement therapy as part of routine clinical care
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Keywords
- pediatric sepsis, septic shock, multiple organ dysfunction syndrome, cytokines
- Medical subject headings
- Shock, Septic, Multiple Organ Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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
Measured: Baseline, 24 hours, 48 hours, 72 hours, Day 5, and Day 7 after CRRT initiation
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start20 May 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion18 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Sepsis-induced Multiple Organ Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phuc Huu Phan, National Children's Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370753
- Sponsor's protocol ID
- IRB-VN01037/IRB00011976/FWA000
- Other IDs
- DT.007/24
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Application of Continuous Renal Replacement Therapy as Adjunctive Support in Pediatric Septic Shock: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07370753
- Acronym / sponsor ID
- IRB-VN01037/IRB00011976/FWA000
- Keywords
- pediatric sepsis, septic shock, multiple organ dysfunction syndrome, cytokines
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 18 Mar 2028 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with septic shock admitted to the PICU and receiving early continuous renal replacement therapy as part of routine clinical care
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
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
4 secondary outcomes
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 serum cytokine levels
Time frame: Baseline, 12 hours, 24 hours, and 48 hours after CRRT initiation
Changes in serum lactate concentration
Time frame: Baseline, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after CRRT initiation
Mortality outcomes
Time frame: up to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome and Septic Shock, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.