Systemic Inflammatory Response Syndrome (SIRS)GAPPSSNCT02728401
Genotypes and Phenotypes in Pediatric SIRS and Sepsis
An observational study of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The aim of this investigation is to longitudinally quantify host gene expression and serum proteins in children with infectious and non-infectious SIRS. The investigators hypothesize that children with non-infectious SIRS, with bacterial infection associated SIRS, or with viral infection associated SIRS will exhibit… Read more about this study
- Who is it for?
- Ages 38 weeks to 18 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2013to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 38 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: INSI group: children who had congenital cardiac defect corrective surgery requiring cardiopulmonary bypass, known to induce an INSI response for ~24 hours thereafter. All children in this group were immune competent and culture negative. CSSS group: children with confirmed or highly suspected infection (microbial culture orders, antimicrobial prescription), SIRS criteria (including fever/hypothermia and leukocytosis/leukopenia), and at least cardiovascular ± pulmonary organ dysfunction. Viral Infection group: children with severe respiratory dysfunction in the presence of PCR -documented viral infection.
Who may be able to join
- Admission to the CICU AND
- Age ~1-18 years AND
- Weight exceeding 10 kg
- Vascular catheter capable of providing the blood draw or anticipated orders for venipuncture for clinical labs AND
- Status post open heart surgery requiring cardiopulmonary bypass AND
- Parents speak English AND
Show all 24Show fewer
- Not previously enrolled in the GAPPSS investigation
- Admitted to the PICU AND
- Age newborn (>38 weeks EGA)-18 years AND
- Weight equal to or greater than 4 kg AND
- Vascular catheter capable of providing the blood draw or anticipated orders for venipuncture for clinical labs AND
- At least one organ dysfunction (severe sepsis) AND
- Parents speak English AND
- SIRS (systemic inflammatory response syndrome) AND
- Strongly suspected or documented source of infection
- Not previously enrolled in the GAPPSS investigation
- Admitted to the PICU AND
- Age newborn (>38 weeks EGA)-18 years AND
- Weight equal to or greater than 4 kg AND
- Vascular catheter capable of providing the blood draw or anticipated orders for venipuncture for clinical labs AND
- Parents speak English AND
- Severe respiratory dysfunction requiring invasive or non-invasive positive pressure mechanical ventilation support AND
- Positive PCR verifying a viral infection
- Not previously enrolled in the GAPPSS investigation
Who cannot join
- Pre- or post-operative culture positive infection OR
- Not expected to survive the CICU stay OR
- Ward of the state OR
- Concurrent malignancy or autoimmune disorder
- CSSS (Clinical Severe Sepsis Syndrome) group: systemic inflammation, in the presence of highly suspected or documented bacterial infection. Children with clinical severe sepsis, n = 40. In this group, the investigators will enroll children who are immunocompetent as well as children who are immunocompromised.
- PICU nosocomial primary infection accounting for the sepsis event
Show all 12Show fewer
- Not expected to survive the PICU stay
- Ward of the state
- Viral Infection group. Severe respiratory dysfunction in the presence of PCR -documented viral infection. Children with clinical severe viral sepsis, n=6. In this group, the investigators will enroll children who are immunocompetent as well as children who are immunocompromised.
- PICU nosocomial primary infection accounting for the sepsis event
- Not expected to survive the PICU stay
- Ward of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Genotypes and Phenotypes in Pediatric SIRS and Sepsis (GAPPSS)
The aim of this investigation is to longitudinally quantify host gene expression and serum proteins in children with infectious and non-infectious SIRS. The investigators hypothesize that children with non-infectious SIRS, with bacterial infection associated SIRS, or with viral infection associated SIRS will exhibit distinct patterns of host gene expression and serum proteins. The investigators further hypothesize that it should be possible to discover sets of mRNA or protein biomarkers that will permit unambiguous diagnosis of non-infectious SIRS, SIRS associated with bacterial infection, and SIRS associated with viral infection.
Read the detailed description
The investigators will undertake a proof-of-concept, pilot, prospective, observational trial that aims to recruit ~90 children from the Seattle Children's Hospital Pediatric Intensive Care Unit (PICU) and Cardiac Intensive Care Unit (CICU). The study will plan to recruit 30 children who are scheduled for surgery to repair congenital cardiac malformations, 15 - 25 immunocompetent children with culture positive sepsis, and 15 - 25 immunocompromised children with culture positive sepsis, and 30-40 children who are polymerase chain reaction (PCR) positive for viral respiratory pathogens (RSV, influenza, parainfluenza, rhinovirus, etc), and who meet the eligibility criteria. In total, accounting for culture negative bacterial sepsis (estimated 40%), the investigators plan to enroll 50 children with sepsis, 30-40 with viral sepsis, and 20 children undergoing surgery for congenital heart disease.
Demographic data will be collected at the time of ICU admission. Illness severity will be quantified by PRISM III and day 1 PELOD scores. Additional measures of sepsis severity will include oxygenation index, saturation index and duration of mechanical ventilation, vasoactive inotropic score and duration of vasoactive-inotropic support and highest serum creatinine on day 1. Resource utilization will be measured as PICU and hospital duration of stay.
For all children enrolled in the study, blood samples will be obtained on study days 1, 2 and 3. For children with sepsis, if cultures remain sterile or PCR negative, no additional research blood samples will be obtained. For children with sepsis and a positive culture or positive PCR by study day 3, additional blood samples will be obtained on the day of PICU discharge.
- Keywords
- inflammation, sepsis, pediatric, transcripts, serum proteins, cardiopulmonary bypass
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| INSI | Infection-negative systemic inflammation (INSI). The INSI group consists of children who have undergone congenital cardiac defect corrective surgery requiring cardiopulmonary bypass, known to induce an INSI response for ~24 hours thereafter; all children in this cohort are culture negative. This group is demarcated further by inclusion \& exclusion criteria (see Eligibility section below). | |
| CSSS | Clinical severe sepsis syndrome (CSSS). Children assigned to the CSSS group had confirmed or highly suspected infection (microbial culture orders, antimicrobial prescription), exhibited 2 or more systemic inflammatory response syndrome criteria (including temperature and leukocyte criteria), and demonstrated at least cardiovascular ± pulmonary organ dysfunction. This group is demarcated further by inclusion \& exclusion criteria (see Eligibility section below). | |
| Viral | The Viral Infection group consists of children who displayed signs and symptoms of severe viral infection, and who tested positive for respiratory viral infection(s) by a molecular virus panel test. These children were clinically evaluated to not have bacterial sepsis. This group is demarcated further by inclusion \& exclusion criteria (see Eligibility section below). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression Levels
Gene expression levels (quantitative) will be compared between CSSS, INSI and viral infection groups, in a search for signatures that can discriminate these groups
Measured: Day 1 of admission to the pediatric intensive care unit (PICU)
Secondary outcomes (1)
Serum Protein Expression Profiles
Serum protein expression profiles (semi-quantitative) will be compared between CSSS and INSI groups, in a search for signatures that can discriminate the two groups
Measured: Day 1 of admission to the pediatric intensive care unit (PICU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start1 May 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response Syndrome (SIRS)Studies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Immunexpress
- Responsible party
- Principal investigator, Jerry Zimmerman, Seattle Children's Hospital
- Investigators
- Jerry J Zimmerman, MD, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728401
- Sponsor's protocol ID
- 14761
- Acronym
- GAPPSS
- Status last verified
- Apr 2018
- First submitted
- 30 Mar 2016
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators plan to publish the results of the GAPPSS study in a peer-reviewed scientific journal. A supplemental digital file associated with this paper will be made publicly available through a web link, and will contain relevant clinical data (with all patients de-identified).
Publications
Mathias B, Mira JC, Larson SD. Pediatric sepsis. Curr Opin Pediatr. 2016 Jun;28(3):380-7. doi: 10.1097/MOP.0000000000000337.
PubMed 26983000Weiss SL, Fitzgerald JC, Pappachan J, Wheeler D, Jaramillo-Bustamante JC, Salloo A, Singhi SC, Erickson S, Roy JA, Bush JL, Nadkarni VM, Thomas NJ; Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Global epidemiology of pediatric severe sepsis: the sepsis prevalence, outcomes, and therapies study. Am J Respir Crit Care Med. 2015 May 15;191(10):1147-57. doi: 10.1164/rccm.201412-2323OC.
PubMed 25734408Zimmerman J, Sullivan E, Sampson D, McHugh L, Yager T, Seldon T. 1024: Sensitive and Specific Diagnosis of Sepsis in Critically Ill Children Utilizing Host Gene Expression. Critical Care Medicine 2015; 43 (12), 258. doi: 10.1097/01.ccm.0000474855.13970.46
McHugh L, Seldon TA, Brandon RA, Kirk JT, Rapisarda A, Sutherland AJ, Presneill JJ, Venter DJ, Lipman J, Thomas MR, Klein Klouwenberg PM, van Vught L, Scicluna B, Bonten M, Cremer OL, Schultz MJ, van der Poll T, Yager TD, Brandon RB. A Molecular Host Response Assay to Discriminate Between Sepsis and Infection-Negative Systemic Inflammation in Critically Ill Patients: Discovery and Validation in Independent Cohorts. PLoS Med. 2015 Dec 8;12(12):e1001916. doi: 10.1371/journal.pmed.1001916. eCollection 2015 Dec.
PubMed 26645559Zimmerman JJ, Sullivan E, Yager TD, Cheng C, Permut L, Cermelli S, McHugh L, Sampson D, Seldon T, Brandon RB, Brandon RA. Diagnostic Accuracy of a Host Gene Expression Signature That Discriminates Clinical Severe Sepsis Syndrome and Infection-Negative Systemic Inflammation Among Critically Ill Children. Crit Care Med. 2017 Apr;45(4):e418-e425. doi: 10.1097/CCM.0000000000002100.
PubMed 27655322Zimmerman JJ, Raman S, Butt WW, Cermelli S, Davis RF, Killien EY, George S, Gibbons KS, Irwin AD, Navalkar KA, Yager TD, Zapf FH, Coin LJM, Schlapbach LJ, Brandon RB. Validation of SeptiCyte RAPID to Discriminate Sepsis From Noninfectious Systemic Inflammation in Critically Ill Children. Pediatr Crit Care Med. 2026 Oct 1;27(10):1195-1206. doi: 10.1097/PCC.0000000000004027. Epub 2026 Aug 7.
PubMed 42565662
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotypes and Phenotypes in Pediatric SIRS and Sepsis (GAPPSS)
- ClinicalTrials.gov ID
- NCT02728401
- Acronym / sponsor ID
- GAPPSS / 14761
- Keywords
- inflammation, sepsis, pediatric, transcripts, serum proteins, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Immunexpress
- Study start
- 1 May 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Apr 2016 (estimated)
- 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.
The aim of this investigation is to longitudinally quantify host gene expression and serum proteins in children with infectious and non-infectious SIRS. The investigators hypothesize that children with non-infectious SIRS, with bacterial infection associated SIRS, or with viral infection associated SIRS will exhibit distinct patterns of host gene expression and serum proteins. The investigators further hypothesize that it should be possible to discover sets of mRNA or protein biomarkers that will permit unambiguous diagnosis of non-infectious SIRS, SIRS associated with bacterial infection, and SIRS associated with viral infection.
Detailed description
The investigators will undertake a proof-of-concept, pilot, prospective, observational trial that aims to recruit ~90 children from the Seattle Children's Hospital Pediatric Intensive Care Unit (PICU) and Cardiac Intensive Care Unit (CICU). The study will plan to recruit 30 children who are scheduled for surgery to repair congenital cardiac malformations, 15 - 25 immunocompetent children with culture positive sepsis, and 15 - 25 immunocompromised children with culture positive sepsis, and 30-40 children who are polymerase chain reaction (PCR) positive for viral respiratory pathogens (RSV, influenza, parainfluenza, rhinovirus, etc), and who meet the eligibility criteria. In total, accounting for culture negative bacterial sepsis (estimated 40%), the investigators plan to enroll 50 children with sepsis, 30-40 with viral sepsis, and 20 children undergoing surgery for congenital heart disease.
Demographic data will be collected at the time of ICU admission. Illness severity will be quantified by PRISM III and day 1 PELOD scores. Additional measures of sepsis severity will include oxygenation index, saturation index and duration of mechanical ventilation, vasoactive inotropic score and duration of vasoactive-inotropic support and highest serum creatinine on day 1. Resource utilization will be measured as PICU and hospital duration of stay.
For all children enrolled in the study, blood samples will be obtained on study days 1, 2 and 3. For children with sepsis, if cultures remain sterile or PCR negative, no additional research blood samples will be obtained. For children with sepsis and a positive culture or positive PCR by study day 3, additional blood samples will be obtained on the day of PICU discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INSI | – | –Infection-negative systemic inflammation (INSI). The INSI group consists of children who have undergone congenital cardiac defect corrective surgery requiring cardiopulmonary bypass, known to induce an INSI response for ~24 hours thereafter; all children in this cohort are culture negative. This group is demarcated further by inclusion \& exclusion criteria (see Eligibility section below). |
| CSSS | – | –Clinical severe sepsis syndrome (CSSS). Children assigned to the CSSS group had confirmed or highly suspected infection (microbial culture orders, antimicrobial prescription), exhibited 2 or more systemic inflammatory response syndrome criteria (including temperature and leukocyte criteria), and demonstrated at least cardiovascular ± pulmonary organ dysfunction. This group is demarcated further by inclusion \& exclusion criteria (see Eligibility section below). |
| Viral | – | –The Viral Infection group consists of children who displayed signs and symptoms of severe viral infection, and who tested positive for respiratory viral infection(s) by a molecular virus panel test. These children were clinically evaluated to not have bacterial sepsis. This group is demarcated further by inclusion \& exclusion criteria (see Eligibility section below). |
Who may qualify
- Ages
- 38 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- INSI group: children who had congenital cardiac defect corrective surgery requiring cardiopulmonary bypass, known to induce an INSI response for ~24 hours thereafter. All children in this group were immune competent and culture negative. CSSS group: children with confirmed or highly suspected infection (microbial culture orders, antimicrobial prescription), SIRS criteria (including fever/hypothermia and leukocytosis/leukopenia), and at least cardiovascular ± pulmonary organ dysfunction. Viral Infection group: children with severe respiratory dysfunction in the presence of PCR -documented viral infection.
Key inclusion criteria (24 listed)
- Admission to the CICU AND
- Age ~1-18 years AND
- Weight exceeding 10 kg
- Vascular catheter capable of providing the blood draw or anticipated orders for venipuncture for clinical labs AND
- Status post open heart surgery requiring cardiopulmonary bypass AND
Key exclusion criteria (12 listed)
- Pre- or post-operative culture positive infection OR
- Not expected to survive the CICU stay OR
- Ward of the state OR
- Concurrent malignancy or autoimmune disorder
- CSSS (Clinical Severe Sepsis Syndrome) group: systemic inflammation, in the presence of highly suspected or documented bacterial infection. Children with clinical severe sepsis, n = 40. In this group, the investigators will enroll children who are immunocompetent as well as children who are immunocompromised.
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
Gene Expression Levels
Time frame: Day 1 of admission to the pediatric intensive care unit (PICU)
Gene expression levels (quantitative) will be compared between CSSS, INSI and viral infection groups, in a search for signatures that can discriminate these groups
1 secondary outcome
Serum Protein Expression Profiles
Time frame: Day 1 of admission to the pediatric intensive care unit (PICU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Background: PubMed 26983000Mathias B, Mira JC, Larson SD. Pediatric sepsis. Curr Opin Pediatr. 2016 Jun;28(3):380-7. doi: 10.1097/MOP.0000000000000337.
- Background: PubMed 25734408Weiss SL, Fitzgerald JC, Pappachan J, Wheeler D, Jaramillo-Bustamante JC, Salloo A, Singhi SC, Erickson S, Roy JA, Bush JL, Nadkarni VM, Thomas NJ; Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Global epidemiology of pediatric severe sepsis: the sepsis prevalence, outcomes, and therapies study. Am J Respir Crit Care Med. 2015 May 15;191(10):1147-57. doi: 10.1164/rccm.201412-2323OC.
- Results publicationZimmerman J, Sullivan E, Sampson D, McHugh L, Yager T, Seldon T. 1024: Sensitive and Specific Diagnosis of Sepsis in Critically Ill Children Utilizing Host Gene Expression. Critical Care Medicine 2015; 43 (12), 258. doi: 10.1097/01.ccm.0000474855.13970.46
- Results publication: PubMed 26645559McHugh L, Seldon TA, Brandon RA, Kirk JT, Rapisarda A, Sutherland AJ, Presneill JJ, Venter DJ, Lipman J, Thomas MR, Klein Klouwenberg PM, van Vught L, Scicluna B, Bonten M, Cremer OL, Schultz MJ, van der Poll T, Yager TD, Brandon RB. A Molecular Host Response Assay to Discriminate Between Sepsis and Infection-Negative Systemic Inflammation in Critically Ill Patients: Discovery and Validation in Independent Cohorts. PLoS Med. 2015 Dec 8;12(12):e1001916. doi: 10.1371/journal.pmed.1001916. eCollection 2015 Dec.
- Results publication: PubMed 27655322Zimmerman JJ, Sullivan E, Yager TD, Cheng C, Permut L, Cermelli S, McHugh L, Sampson D, Seldon T, Brandon RB, Brandon RA. Diagnostic Accuracy of a Host Gene Expression Signature That Discriminates Clinical Severe Sepsis Syndrome and Infection-Negative Systemic Inflammation Among Critically Ill Children. Crit Care Med. 2017 Apr;45(4):e418-e425. doi: 10.1097/CCM.0000000000002100.
- Derived from this study: PubMed 42565662Zimmerman JJ, Raman S, Butt WW, Cermelli S, Davis RF, Killien EY, George S, Gibbons KS, Irwin AD, Navalkar KA, Yager TD, Zapf FH, Coin LJM, Schlapbach LJ, Brandon RB. Validation of SeptiCyte RAPID to Discriminate Sepsis From Noninfectious Systemic Inflammation in Critically Ill Children. Pediatr Crit Care Med. 2026 Oct 1;27(10):1195-1206. doi: 10.1097/PCC.0000000000004027. Epub 2026 Aug 7.
- Individual participant dataSharing planned: Yes. The investigators plan to publish the results of the GAPPSS study in a peer-reviewed scientific journal. A supplemental digital file associated with this paper will be made publicly available through a web link, and will contain relevant clinical data (with all patients de-identified).
Related trials for Systemic Inflammatory Response Syndrome (SIRS)
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
RecruitingPhase 3
THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL
Sepsis
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.
Jerry J Zimmerman, MD, PhD principal investigator
Seattle Children's Hospital
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 Systemic Inflammatory Response Syndrome (SIRS) and Sepsis, run by Seattle Children's Hospital at 1 site in United States.
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 24 inclusion and 12 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: finished, as of the sponsor's last update on 19 Apr 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gene Expression Levels (time frame: Day 1 of admission to the pediatric intensive care unit (PICU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728401, which also lists 6 linked publications.
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 19 Apr 2018.