Septic ShockLAPSENCT01415180
Life After Pediatric Sepsis Evaluation
An observational study of Septic Shock, run by Seattle Children's Hospital at 11 sites in United States.
Trial summary
Sepsis represents the leading cause of childhood mortality worldwide. However, as distinct from adult medicine, there exists a large knowledge gap regarding long term health related quality of life (HRQL) and functional status (FS) following pediatric sepsis. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Septic Shock
- How many people
- 389 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jun 2013to 1 Jun 2018
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 0-18 admitted to a PICU for septic shock
Who may be able to join
- Age 44 weeks EGA to 18 years
- Admitted to the PICU for the sepsis event
- Evidence of SIRS including fever/ hypothermia and leukocytosis/leukopenia
- Documented or suspected infection
- Cardiovascular organ dysfunction with need for vasoactive-inotropic support
Who cannot join
- Lack of commitment to aggressive sepsis therapy OR
- Ward of the state OR
- Sepsis event associated with a PICU-acquired nosocomial infection OR
- Parents do not speak English or Spanish OR
- Previously enrolled in the LAPSE study
- Enrollment not possible within 12 hours of PICU admission
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Mott Children's Hospital
Ann Arbor, Michigan
Texas A&M University
College Station, Texas
Children's Hospital of Michigan
Detroit, Michigan
Children's Hospital of Los Angeles
Los Angeles, California
Mattel Children's Hospital
Los Angeles, California
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Phoenix Children's Hospital
Phoenix, Arizona
Pittsburgh Children's Hospital
Pittsburgh, Pennsylvania
University of Utah
Salt Lake City, Utah
Seattle Children's Hospital
Seattle, Washington, 98105
National Children's Hospital
Washington D.C., District of Columbia
About this study
Sepsis represents the leading cause of childhood mortality worldwide. However, as distinct from adult medicine, there exists a large knowledge gap regarding long term health related quality of life (HRQL) and functional status (FS) following pediatric sepsis. This lack of sepsis outcomes data is critical because failure to identify children at risk for sepsis associated HRQL/FS deterioration may delay delivery of crucial rehabilitation medicine efforts to facilitate recovery. Moreover, failure to identify mechanisms of sepsis associated HRQL/FS deterioration may impede development of novel, effective interventions for these children. For the first time the LAPSE investigation will quantify deterioration of HRQL/FS among children surviving sepsis. We will measure the incidence, magnitude and duration of HRQL/FS alterations associated with pediatric septic shock, and examine clinical, sociodemographic, and parent/family factors potentially associated with such adverse outcomes. Because sepsis affects a heterogeneous group of children, long term morbidity associated with sepsis likely depends on premorbid health status and parent, family and home characteristics, as well as children's clinical course during sepsis critical illness. Mechanisms underlying adverse sepsis outcomes among children are poorly understood at this time. Clinically multiple organ dysfunction syndrome (MODS) has been clearly linked to sepsis mortality. To begin to understand pathophysiology underlying pediatric sepsis morbidity, this investigation will seek to identify evidence for association of HRQL/FS alterations following sepsis with intensity and duration of sepsis mediated organ dysfunction as well as with pre-existing comorbidities and parent, family, and home characteristics. The long-term goal of this research program is to timely identify children at high risk of sepsis mediated HRQL/FS deterioration and ultimately to design effective interventions to minimize such risk. The primary objectives of this investigation are to comprehensively characterize HRQL/FS trajectory and to critically examine the potential role of sepsis mediated organ dysfunction as well as pre-existing comorbidities and parent, family, and home characteristics as risk factors for the adverse outcomes. The central hypothesis is that intensity of sepsis organ dysfunction will predict magnitude of HRQL/FS deterioration. We also hypothesize that the trajectory towards baseline HRQL/FS following the sepsis event will also depend on pre-existing co-morbidities and parent, family, and home, and characteristics. Knowledge of these potential mechanisms will ultimately facilitate development of targeted interventions to maximize HRQL/FS among children surviving sepsis.
Read the detailed description
In-hospital pediatric sepsis mortality has decreased substantially, but long-term mortality and morbidity among children initially surviving sepsis, is unknown. Accordingly, the Life After Pediatric Sepsis Evaluation investigation was conducted to describe the trajectory of mortality and health-related quality of life morbidity and critical illness factors associated with these outcomes for children encountering community-acquired septic shock.
Design: Prospective, cohort-outcome study, conducted 2013-2017. Setting: Twelve academic pediatric intensive care units (PICUs) in the United States.
Patients: Critically ill children, 1 month to 18 years, with community-acquired septic shock requiring vasoactive-inotropic support. Interventions: Demographic, infection, and illness severity data were collected at PICU admission. Organ dysfunction and resource utilization data were collected during PICU stay. Serial parent proxy-report health-related quality of life assessments were obtained at baseline, 7 days, and 1, 3, 6, and 12 months following PICU admission utilizing the Pediatric Quality of Life Inventory or Stein-Jessop Functional Status Scale.
- Conditions
- Septic Shock
- Keywords
- sepsis, health related quality of life, functional status, chronic comorbid conditions, organ dysfunction
- Medical subject headings
- Shock, Septic, Sepsis
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 |
|---|---|---|
| Children: previously healthy | Previously healthy children, without chronic disease prior to the sepsis episode, expected to comprise about 50-60% of the total study population. | |
| Children: chronic, complex conditions | Children with chronic, complex conditions prior to the sepsis episode, expected to comprise about 40-50% of the study population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aim 1: Measure alterations in HRQL/FS longitudinally among children with septic shock.
Hypotheses related to this specific aim include:
1.1 A majority of children with septic shock will demonstrate declination of generic HRQL/FS comparing baseline and one month post-enrollment measures. [Incidence]
1.2 Significant deterioration in generic HRQL/FS will occur among children with septic shock comparing baseline and one month post-enrollment measures. [Magnitude]
1.3 Normalization of HRQL/FS will be observed by 12 months for the majority of children surviving septic shock. [Duration]
Measured: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
Secondary outcomes (2)
Specific Aim 2: Determine the association between the magnitude of septic shock related HRQL/FS deterioration with validated measures of sepsis-mediated organ dysfunction.
Hypotheses related to this specific aim include:
2.1 Magnitude of septic shock related generic HRQL/FS deterioration will be associated with area under the curve of validated organ dysfunction measures assessed daily during PICU stay for the sepsis event.
Measured: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
Specific Aim 3: Describe the association between longitudinal changes in HRQL/FS following septic shock with measures of parent, family, and home characteristics and pre-existing comorbidities.
Hypotheses related to this specific aim include:
3.1 Family and home characteristics (socio-economic status, parental educational attainment, family function, parental distress, and insurance status) will be associated with duration and magnitude of HRQL/FS alterations.
3.2 Complexity of chronic comorbid conditions will be associated with duration and magnitude of HRQL/FS alterations
Measured: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study start1 Jun 2013
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The National Collaborative Pediatric Critical Care Research Network, Children's Hospital Los Angeles, Children's Hospital of Michigan, Children's Hospital of Philadelphia, University of Pittsburgh, University of California, Los Angeles, C.S. Mott Children's Hospital, Children's National Research Institute, Phoenix Children's Hospital, Texas A&M University
- 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
- NCT01415180
- Sponsor's protocol ID
- SeattleChildrens
- Acronym
- LAPSE
- Status last verified
- Dec 2022
- First submitted
- 10 Aug 2011
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zimmerman JJ, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Meert KL, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Wong H, Chima RS, Holubkov R, Coleman W, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock K, Dean JM, Reeder RW; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Critical Illness Factors Associated With Long-Term Mortality and Health-Related Quality of Life Morbidity Following Community-Acquired Pediatric Septic Shock. Crit Care Med. 2020 Mar;48(3):319-328. doi: 10.1097/CCM.0000000000004122.
PubMed 32058369Zimmerman JJ, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Meert KL, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Wong H, Chima RS, Holubkov R, Coleman W, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock K, Dean JM, Reeder RW; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Trajectory of Mortality and Health-Related Quality of Life Morbidity Following Community-Acquired Pediatric Septic Shock. Crit Care Med. 2020 Mar;48(3):329-337. doi: 10.1097/CCM.0000000000004123.
PubMed 32058370Meert KL, Reeder R, Maddux AB, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Chima RS, Holubkov R, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock KB, Dean JM, Zimmerman JJ; and the Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Trajectories and Risk Factors for Altered Physical and Psychosocial Health-Related Quality of Life After Pediatric Community-Acquired Septic Shock. Pediatr Crit Care Med. 2020 Oct;21(10):869-878. doi: 10.1097/PCC.0000000000002374.
PubMed 32667767Murphy LK, Palermo TM, Meert KL, Reeder R, Dean JM, Banks R, Berg RA, Carcillo JA, Chima R, McGalliard J, Haaland W, Holubkov R, Mourani PM, Pollack MM, Sapru A, Sorenson S, Varni JW, Zimmerman J. Longitudinal Trajectories of Caregiver Distress and Family Functioning After Community-Acquired Pediatric Septic Shock. Pediatr Crit Care Med. 2020 Sep;21(9):787-796. doi: 10.1097/PCC.0000000000002404.
PubMed 32541376Starr MC, Banks R, Reeder RW, Fitzgerald JC, Pollack MM, Meert KL, McQuillen PS, Mourani PM, Chima RS, Sorenson S, Varni JW, Hingorani S, Zimmerman JJ; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Severe Acute Kidney Injury Is Associated With Increased Risk of Death and New Morbidity After Pediatric Septic Shock. Pediatr Crit Care Med. 2020 Sep;21(9):e686-e695. doi: 10.1097/PCC.0000000000002418.
PubMed 32569242
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life After Pediatric Sepsis Evaluation
- ClinicalTrials.gov ID
- NCT01415180
- Acronym / sponsor ID
- LAPSE / SeattleChildrens
- Conditions
- Septic Shock
- Keywords
- sepsis, health related quality of life, functional status, chronic comorbid conditions, organ dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- The National Collaborative Pediatric Critical Care Research Network, Children's Hospital Los Angeles, Children's Hospital of Michigan, Children's Hospital of Philadelphia, University of Pittsburgh, University of California, Los Angeles, C.S. Mott Children's Hospital, Children's National Research Institute, Phoenix Children's Hospital, Texas A&M University
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 11 Aug 2011 (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.
Sepsis represents the leading cause of childhood mortality worldwide. However, as distinct from adult medicine, there exists a large knowledge gap regarding long term health related quality of life (HRQL) and functional status (FS) following pediatric sepsis. This lack of sepsis outcomes data is critical because failure to identify children at risk for sepsis associated HRQL/FS deterioration may delay delivery of crucial rehabilitation medicine efforts to facilitate recovery. Moreover, failure to identify mechanisms of sepsis associated HRQL/FS deterioration may impede development of novel, effective interventions for these children. For the first time the LAPSE investigation will quantify deterioration of HRQL/FS among children surviving sepsis. We will measure the incidence, magnitude and duration of HRQL/FS alterations associated with pediatric septic shock, and examine clinical, sociodemographic, and parent/family factors potentially associated with such adverse outcomes. Because sepsis affects a heterogeneous group of children, long term morbidity associated with sepsis likely depends on premorbid health status and parent, family and home characteristics, as well as children's clinical course during sepsis critical illness. Mechanisms underlying adverse sepsis outcomes among children are poorly understood at this time. Clinically multiple organ dysfunction syndrome (MODS) has been clearly linked to sepsis mortality. To begin to understand pathophysiology underlying pediatric sepsis morbidity, this investigation will seek to identify evidence for association of HRQL/FS alterations following sepsis with intensity and duration of sepsis mediated organ dysfunction as well as with pre-existing comorbidities and parent, family, and home characteristics. The long-term goal of this research program is to timely identify children at high risk of sepsis mediated HRQL/FS deterioration and ultimately to design effective interventions to minimize such risk. The primary objectives of this investigation are to comprehensively characterize HRQL/FS trajectory and to critically examine the potential role of sepsis mediated organ dysfunction as well as pre-existing comorbidities and parent, family, and home characteristics as risk factors for the adverse outcomes. The central hypothesis is that intensity of sepsis organ dysfunction will predict magnitude of HRQL/FS deterioration. We also hypothesize that the trajectory towards baseline HRQL/FS following the sepsis event will also depend on pre-existing co-morbidities and parent, family, and home, and characteristics. Knowledge of these potential mechanisms will ultimately facilitate development of targeted interventions to maximize HRQL/FS among children surviving sepsis.
Detailed description
In-hospital pediatric sepsis mortality has decreased substantially, but long-term mortality and morbidity among children initially surviving sepsis, is unknown. Accordingly, the Life After Pediatric Sepsis Evaluation investigation was conducted to describe the trajectory of mortality and health-related quality of life morbidity and critical illness factors associated with these outcomes for children encountering community-acquired septic shock.
Design: Prospective, cohort-outcome study, conducted 2013-2017. Setting: Twelve academic pediatric intensive care units (PICUs) in the United States.
Patients: Critically ill children, 1 month to 18 years, with community-acquired septic shock requiring vasoactive-inotropic support. Interventions: Demographic, infection, and illness severity data were collected at PICU admission. Organ dysfunction and resource utilization data were collected during PICU stay. Serial parent proxy-report health-related quality of life assessments were obtained at baseline, 7 days, and 1, 3, 6, and 12 months following PICU admission utilizing the Pediatric Quality of Life Inventory or Stein-Jessop Functional Status Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children: previously healthy | – | –Previously healthy children, without chronic disease prior to the sepsis episode, expected to comprise about 50-60% of the total study population. |
| Children: chronic, complex conditions | – | –Children with chronic, complex conditions prior to the sepsis episode, expected to comprise about 40-50% of the study population. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 0-18 admitted to a PICU for septic shock
Key inclusion criteria (5 listed)
- Age 44 weeks EGA to 18 years
- Admitted to the PICU for the sepsis event
- Evidence of SIRS including fever/ hypothermia and leukocytosis/leukopenia
- Documented or suspected infection
- Cardiovascular organ dysfunction with need for vasoactive-inotropic support
Key exclusion criteria (6 listed)
- Lack of commitment to aggressive sepsis therapy OR
- Ward of the state OR
- Sepsis event associated with a PICU-acquired nosocomial infection OR
- Parents do not speak English or Spanish OR
- Previously enrolled in the LAPSE study
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
Specific Aim 1: Measure alterations in HRQL/FS longitudinally among children with septic shock.
Time frame: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
Hypotheses related to this specific aim include: 1.1 A majority of children with septic shock will demonstrate declination of generic HRQL/FS comparing baseline and one month post-enrollment measures. [Incidence] 1.2 Significant deterioration in generic HRQL/FS will occur among children with septic shock comparing baseline and one month post-enrollment measures. [Magnitude] 1.3 Normalization of HRQL/FS will be observed by 12 months for the majority of children surviving septic shock. [Duration]
2 secondary outcomes
Specific Aim 2: Determine the association between the magnitude of septic shock related HRQL/FS deterioration with validated measures of sepsis-mediated organ dysfunction.
Time frame: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
Specific Aim 3: Describe the association between longitudinal changes in HRQL/FS following septic shock with measures of parent, family, and home characteristics and pre-existing comorbidities.
Time frame: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
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 6 Dec 2022.
- Results publication: PubMed 32058369Zimmerman JJ, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Meert KL, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Wong H, Chima RS, Holubkov R, Coleman W, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock K, Dean JM, Reeder RW; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Critical Illness Factors Associated With Long-Term Mortality and Health-Related Quality of Life Morbidity Following Community-Acquired Pediatric Septic Shock. Crit Care Med. 2020 Mar;48(3):319-328. doi: 10.1097/CCM.0000000000004122.
- Results publication: PubMed 32058370Zimmerman JJ, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Meert KL, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Wong H, Chima RS, Holubkov R, Coleman W, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock K, Dean JM, Reeder RW; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Trajectory of Mortality and Health-Related Quality of Life Morbidity Following Community-Acquired Pediatric Septic Shock. Crit Care Med. 2020 Mar;48(3):329-337. doi: 10.1097/CCM.0000000000004123.
- Results publication: PubMed 32667767Meert KL, Reeder R, Maddux AB, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Chima RS, Holubkov R, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock KB, Dean JM, Zimmerman JJ; and the Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Trajectories and Risk Factors for Altered Physical and Psychosocial Health-Related Quality of Life After Pediatric Community-Acquired Septic Shock. Pediatr Crit Care Med. 2020 Oct;21(10):869-878. doi: 10.1097/PCC.0000000000002374.
- Results publication: PubMed 32541376Murphy LK, Palermo TM, Meert KL, Reeder R, Dean JM, Banks R, Berg RA, Carcillo JA, Chima R, McGalliard J, Haaland W, Holubkov R, Mourani PM, Pollack MM, Sapru A, Sorenson S, Varni JW, Zimmerman J. Longitudinal Trajectories of Caregiver Distress and Family Functioning After Community-Acquired Pediatric Septic Shock. Pediatr Crit Care Med. 2020 Sep;21(9):787-796. doi: 10.1097/PCC.0000000000002404.
- Results publication: PubMed 32569242Starr MC, Banks R, Reeder RW, Fitzgerald JC, Pollack MM, Meert KL, McQuillen PS, Mourani PM, Chima RS, Sorenson S, Varni JW, Hingorani S, Zimmerman JJ; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Severe Acute Kidney Injury Is Associated With Increased Risk of Death and New Morbidity After Pediatric Septic Shock. Pediatr Crit Care Med. 2020 Sep;21(9):e686-e695. doi: 10.1097/PCC.0000000000002418.
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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.
Jerry J. Zimmerman, MD, PhD principal investigator
Seattle Children's Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Seattle Children's Hospital at 11 sites 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 5 inclusion and 6 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 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Specific Aim 1: Measure alterations in HRQL/FS longitudinally among children with septic shock. (time frame: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis). 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 NCT01415180, which also lists 5 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 6 Dec 2022.