SepsisNCT01890928
Gluconeogenesis Rates and Its Precursors in Pediatric Sepsis
An observational study of Sepsis and Hyperglycemia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Critically ill children have abnormal utilization of nutrients such as glucose, lipids and protein. Often sick children have increased glucose concentrations in blood. However, the origin of the high glucose has not been determined in these populations. Read more about this study
- Who is it for?
- Ages 5 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Hyperglycemia, Critical Illness
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2013
- 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 5 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Septic pediatric subjects: A total of 45 critically ill children age 5-19 years with diagnosis of sepsis, as defined by the International Sepsis Consensus Conference. Healthy subjects: A total of 30 healthy adolescents 13-19 years matched for age, gender, Tanner and BMI to serve as controls. A Dexa scan will be obtained to determine lean body mass.
Who may be able to join
- Children age 5-19 years.
- Diagnosis of severe sepsis diagnosed as clinical sepsis syndrome (requires two of the following criteria):
- Source of infection
- Fever or Hypothermia
- Leukocytosis or Leucopenia
- Poor organ perfusion (such as delayed capillary refill or decreased urine output or hypotension)
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- Bacteremic sepsis demonstrated by positive blood culture
- Indwelling central and/or arterial venous access as per clinical indication.
- Age 13-19 years.
- Evidence of health as assessed by physical exam, and laboratory tests, including: Hematocrit no less than 36% for males and no less than 37% for females, white blood cell count from 5-10,000.
- Chemistries within normal range, normal urine analysis, and fasting plasma glucose level no less than 60 or greater than 104 mg/dL.
- Lean Children with BMI of 18-24.
- Obese Children with BMI of 30 or greater.
Who cannot join
- Patients with metabolic diseases (i.e.: urea cycle disorders, cystinuria, Insulin dependent diabetes mellitus, etc.).
- Pregnancy.
- Primary liver failure.
- Healthy Children:
- Tobacco use.
- Pregnancy.
- Taking any prescription medication that affects amino acid metabolism, i.e., glucocorticoids.
- History of acute or chronic illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gluconeogenesis Rates and Its Source in Critically Ill Adolescents
Critically ill children have abnormal utilization of nutrients such as glucose, lipids and protein. Often sick children have increased glucose concentrations in blood. However, the origin of the high glucose has not been determined in these populations. There is a close interrelationship between protein and energy metabolism. An increase in the energy supply will not promote nitrogen retention unless the amino acid supply is adequate, and conversely, an increased amino acid supply will be useless if energy is limiting, hence the importance of adequate protein and energy intake. Our study aims to investigate the protein-energy interactions in critically ill septic children and adolescents with the objective to eventually provide the best nutritional support for these patients.
Read the detailed description
This is an observational study, aimed at exploring:
- gluconeogenesis rates ii) sources of gluconeogenesis and pyruvate cycling, and iii) protein kinetics in critically ill children and adolescents, and its differences by age group, as well as in comparison to healthy adolescents. The study size will include 45 critically ill septic, pediatric patients (22 children at 5-12 years of age and 23 adolescents' at 13-19 years of age), male and females admitted to the pediatric intensive care unit (PICU) at Children's Medical Center, Dallas. The minimal subject's weight will be 17kg. Additionally, 30 healthy adolescents matched by age, gender, BMI and Tanner stage will be studied at the Clinical Translational Research Center at Zale Lipshy Hospital, to serve as healthy adolescent controls. The number of subjects includes an expected drop out rate of about 20%, in order to obtain 18 patients with complete data in each group. Patients will receive nutritional support as per standard care. This study will yield important knowledge and may lead in the future to changes in the current practice on the management of critically ill pediatric patients in the PICU.
- Conditions
- Sepsis, Hyperglycemia, Critical Illness
- Keywords
- Gluconeogenesis, Glycogenolysis, Pyruvate cycling, Glucose production rates, Mitochondria, Acylcarnitines
- Medical subject headings
- Sepsis, Hyperglycemia, Critical Illness
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 |
|---|---|---|
| Critically Ill Septic Pediatric Patients | Age 5-12 years; weight ≥ 17kg and Age 13-19 years, males and females | |
| Healthy Adolescents | Age 13-19 years, males and females |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gluconeogenesis Rates
Rates of gluconeogenesis from glycerol, lactate/amino acids in relation to protein synthesis, breakdown and balance, and pyruvate cycling among different age groups (children vs. adolescents) and in comparison with healthy adolescents.
Measured: 24 hours
Secondary outcomes (1)
Metabolic Source for Gluconeogenesis
Rates of gluconeogenesis from glycerol, lactate/amino acids in relation to severity of the disease, as determined by,
- PRISM Score III, which is predictor of mortality in pediatric critically ill patients,
- Degree of inflammation as assessed by plasma C reactive protein,
- Highest inotrope doses and length of administration,
- Ventilator-free days, ICU length of stay and length of hospital stay.
Measured: 24 hours during study and overall ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Principal investigator, Leticia Castillo, University of Texas Southwestern Medical Center
- Investigators
- Leticia Castillo, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890928
- Sponsor's protocol ID
- STU-072010-051
- Status last verified
- Apr 2016
- First submitted
- 27 Jun 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluconeogenesis Rates and Its Source in Critically Ill Adolescents
- ClinicalTrials.gov ID
- NCT01890928
- Acronym / sponsor ID
- STU-072010-051
- Conditions
- Sepsis, Hyperglycemia, Critical Illness
- Keywords
- Gluconeogenesis, Glycogenolysis, Pyruvate cycling, Glucose production rates, Mitochondria, Acylcarnitines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- University of Texas
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Jul 2013 (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.
Critically ill children have abnormal utilization of nutrients such as glucose, lipids and protein. Often sick children have increased glucose concentrations in blood. However, the origin of the high glucose has not been determined in these populations. There is a close interrelationship between protein and energy metabolism. An increase in the energy supply will not promote nitrogen retention unless the amino acid supply is adequate, and conversely, an increased amino acid supply will be useless if energy is limiting, hence the importance of adequate protein and energy intake. Our study aims to investigate the protein-energy interactions in critically ill septic children and adolescents with the objective to eventually provide the best nutritional support for these patients.
Detailed description
This is an observational study, aimed at exploring:
- gluconeogenesis rates ii) sources of gluconeogenesis and pyruvate cycling, and iii) protein kinetics in critically ill children and adolescents, and its differences by age group, as well as in comparison to healthy adolescents. The study size will include 45 critically ill septic, pediatric patients (22 children at 5-12 years of age and 23 adolescents' at 13-19 years of age), male and females admitted to the pediatric intensive care unit (PICU) at Children's Medical Center, Dallas. The minimal subject's weight will be 17kg. Additionally, 30 healthy adolescents matched by age, gender, BMI and Tanner stage will be studied at the Clinical Translational Research Center at Zale Lipshy Hospital, to serve as healthy adolescent controls. The number of subjects includes an expected drop out rate of about 20%, in order to obtain 18 patients with complete data in each group. Patients will receive nutritional support as per standard care. This study will yield important knowledge and may lead in the future to changes in the current practice on the management of critically ill pediatric patients in the PICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Septic Pediatric Patients | – | –Age 5-12 years; weight ≥ 17kg and Age 13-19 years, males and females |
| Healthy Adolescents | – | –Age 13-19 years, males and females |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Septic pediatric subjects: A total of 45 critically ill children age 5-19 years with diagnosis of sepsis, as defined by the International Sepsis Consensus Conference. Healthy subjects: A total of 30 healthy adolescents 13-19 years matched for age, gender, Tanner and BMI to serve as controls. A Dexa scan will be obtained to determine lean body mass.
Key inclusion criteria (13 listed)
- Children age 5-19 years.
- Diagnosis of severe sepsis diagnosed as clinical sepsis syndrome (requires two of the following criteria):
- Indwelling central and/or arterial venous access as per clinical indication.
- Age 13-19 years.
- Evidence of health as assessed by physical exam, and laboratory tests, including: Hematocrit no less than 36% for males and no less than 37% for females, white blood cell count from 5-10,000.
Key exclusion criteria (8 listed)
- Patients with metabolic diseases (i.e.: urea cycle disorders, cystinuria, Insulin dependent diabetes mellitus, etc.).
- Pregnancy.
- Primary liver failure.
- Tobacco use.
- Pregnancy.
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
Gluconeogenesis Rates
Time frame: 24 hours
Rates of gluconeogenesis from glycerol, lactate/amino acids in relation to protein synthesis, breakdown and balance, and pyruvate cycling among different age groups (children vs. adolescents) and in comparison with healthy adolescents.
1 secondary outcome
Metabolic Source for Gluconeogenesis
Time frame: 24 hours during study and overall ICU admission
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 28 Apr 2016.
- Individual participant dataSharing planned: Yes
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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.
Leticia Castillo, MD principal investigator
University of Texas Southwestern Medical Center
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 Sepsis and Hyperglycemia, run by The Cleveland Clinic 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 13 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: finished, as of the sponsor's last update on 28 Apr 2016. 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?
Gluconeogenesis Rates (time frame: 24 hours). 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 28 Apr 2016.