Congenital Heart DiseaseNCT00284570
Pro-Calcitonin Levels Following Pediatric Cardiac Surgery
An observational study of Congenital Heart Disease and Sepsis, run by Emory University at 1 site in United States.
Trial summary
First, we, the researchers, hope to find out the PCT response to heart surgery in children by taking blood before surgery and each day for four days after surgery. These blood draws will help us figure out the typical Procalcitonin (PCT) response, the normal increase in PCT after heart surgery, and when the PCT level… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Congenital Heart Disease, Sepsis, Infection
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2007
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The study patients will be recruited from Children's Healthcare of Atlanta at Egleston. The patients will be in the pre-operative clinic, Cardiac Intensive Care Unit or the Cardiac Stepdown Unit.
Who may be able to join
- Patients with congenital heart disease
- Undergoing cardiopulmonary bypass and cardiac surgery
- Newborn (full term) to up to 6 years of age
Who cannot join
- Premature (less than 37 weeks)
- 6 years of age or older
- Intercurrent illness at time of surgery
- Orthotopic organ transplant recipient
- Pre-operative extra-corporeal support (ECMO)
- Acquired heart disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: ProCalcitonin in the Pediatric Surgical Patient, Evaluation of a New Marker of Infection
First, we, the researchers, hope to find out the PCT response to heart surgery in children by taking blood before surgery and each day for four days after surgery. These blood draws will help us figure out the typical Procalcitonin (PCT) response, the normal increase in PCT after heart surgery, and when the PCT level returns to baseline.
Second, we, the researchers, hope to determine the accuracy of PCT as a marker of infection.
Hypothesis
Our hypothesis is that Procalcitonin is superior to other currently used markers of infection and will prove to be a clinically useful tool for evaluation of infection in children following cardiac surgery.
Read the detailed description
In this research study, we want to look at the difficulty in identifying infections in children who have heart surgery. We also want to look at differentiating between actual infections and the normal post-surgery course that patients go through. We use a number of tools in the Intensive Care Unit to pick out children at risk for an infection. These tools are the physical examination, a fever, white blood cell count, and C-reactive Protein (CRP) level. When a patient has an infection, they usually have a fever, have a high white blood cell count, and have an increased CRP level. However, these are not always correct. The identification of infection remains a challenge and the laboratory markers of infection (white blood cell count and CRP) that are used now are not perfect.
A new marker of infection, Procalcitonin (PCT), has been found and has been tested in adults and children. PCT has recently been approved by the Food and Drug Administration (FDA) as a marker of infection. PCT has been shown to be a more accurate marker of infection for some groups of patients.
Prior work on a small number of children shows that PCT increases shortly just from heart surgery itself, even without infection. There is little information published about how accurate PCT is for identifying infection in the child heart population. In order to use PCT in our patients, we need to know what the normal levels of PCT are after surgery. Thus, when an infection does happen, we can identify it. We also need to take PCT levels when patients are thought to have infections. We will then need to watch for an infection over the next few days to see if the PCT level rises and can actually predict the presence an infection.
Goals:
- Determine the Procalcitonin response to cardiopulmonary bypass in children undergoing open-heart surgery. Cardiopulmonary bypass causes a pro-inflammatory state in the patient, and associated rise in Procalcitonin. The ability to use PCT as a marker for infection will require knowledge of its typical response to bypass and the time course to return to baseline.
- Determine the accuracy of Procalcitonin as a marker of infection, and to compare and contrast these findings with currently used laboratory markers.
Specific Aims
- Evaluate PCT in the postoperative pediatric cardiac surgical patient as a marker for infection and sepsis.
- Evaluate PCT's response to cardiopulmonary bypass, and as a predictor of outcome following cardiac surgery.
- Compare PCT to other markers of inflammation and infection (C-reactive protein and white blood cell response).
By doing this study, we hope to find out two things. First, we hope to find out the PCT response to heart surgery in children by taking blood before surgery and each day for four days after surgery. These blood draws will help us figure out the typical PCT response, the normal increase in PCT after heart surgery, and when the PCT level returns to baseline.
Second, we hope to determine the accuracy of PCT as a marker of infection. Whenever we think a patient may have an infection, it is routine care to take some blood and run lab tests such as a white blood cell count, blood culture, and a C-reactive protein level. Patients in the study will also have an additional 10 drops of blood taken for a PCT level at the same time as the routine blood draw. Even though patients may show signs of an infection, the routine blood test do not always come back positive for an infection. We will compare the routine blood test results (positive or negative for an infection) with the PCT level taken at the same time. If most patients with an infection also have a rise in PCT and those patients without an infection have a normal PCT, then we will prove that PCT is a good, accurate marker for infection in our patients.
This research will help us study infection in our patients. It will help distinguish patients with infection, what the risk factors are, how they are treated, and the response to infection. This information will potentially allow us to use an improved test for identifying infection in a high-risk population of children. Patients in the research project will continue to receive the standard of care treatment after heart surgery and there will be no changes in their care during the study.
- Conditions
- Congenital Heart Disease, Sepsis, Infection
- Keywords
- pediatrics, congenital heart disease, cardiac, cardiopulmonary bypass, infection, sepsis, postoperative, marker for infection, inflammation, cardiac surgery
- Medical subject headings
- Heart Defects, Congenital, Sepsis, Infections, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2006
- Study completionMar 2007
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 Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Kevin O. Maher, MD, Emory University
- Investigators
- Kevin Maher, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284570
- Sponsor's protocol ID
- IRB00002022
- Status last verified
- Nov 2013
- First submitted
- 30 Jan 2006
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
PubMed 12700374Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PubMed 11445675Hauser GJ, Chan MM, Casey WF, Midgley FM, Holbrook PR. Immune dysfunction in children after corrective surgery for congenital heart disease. Crit Care Med. 1991 Jul;19(7):874-81. doi: 10.1097/00003246-199107000-00009.
PubMed 2055075Jarvis WR, Edwards JR, Culver DH, Hughes JM, Horan T, Emori TG, Banerjee S, Tolson J, Henderson T, Gaynes RP, et al. Nosocomial infection rates in adult and pediatric intensive care units in the United States. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):185S-191S. doi: 10.1016/0002-9343(91)90367-7.
PubMed 1928163Mayhall CG. Diagnosis and management of infections of implantable devices used for prolonged venous access. Curr Clin Top Infect Dis. 1992;12:83-110. No abstract available.
PubMed 1642805Galetto-Lacour A, Zamora SA, Gervaix A. Bedside procalcitonin and C-reactive protein tests in children with fever without localizing signs of infection seen in a referral center. Pediatrics. 2003 Nov;112(5):1054-60. doi: 10.1542/peds.112.5.1054.
PubMed 14595045
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProCalcitonin in the Pediatric Surgical Patient, Evaluation of a New Marker of Infection
- ClinicalTrials.gov ID
- NCT00284570
- Acronym / sponsor ID
- IRB00002022
- Conditions
- Congenital Heart Disease, Sepsis, Infection
- Keywords
- pediatrics, congenital heart disease, cardiac, cardiopulmonary bypass, infection, sepsis, postoperative, marker for infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Jan 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 1 Feb 2006 (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.
First, we, the researchers, hope to find out the PCT response to heart surgery in children by taking blood before surgery and each day for four days after surgery. These blood draws will help us figure out the typical Procalcitonin (PCT) response, the normal increase in PCT after heart surgery, and when the PCT level returns to baseline.
Second, we, the researchers, hope to determine the accuracy of PCT as a marker of infection.
Hypothesis
Our hypothesis is that Procalcitonin is superior to other currently used markers of infection and will prove to be a clinically useful tool for evaluation of infection in children following cardiac surgery.
Detailed description
In this research study, we want to look at the difficulty in identifying infections in children who have heart surgery. We also want to look at differentiating between actual infections and the normal post-surgery course that patients go through. We use a number of tools in the Intensive Care Unit to pick out children at risk for an infection. These tools are the physical examination, a fever, white blood cell count, and C-reactive Protein (CRP) level. When a patient has an infection, they usually have a fever, have a high white blood cell count, and have an increased CRP level. However, these are not always correct. The identification of infection remains a challenge and the laboratory markers of infection (white blood cell count and CRP) that are used now are not perfect.
A new marker of infection, Procalcitonin (PCT), has been found and has been tested in adults and children. PCT has recently been approved by the Food and Drug Administration (FDA) as a marker of infection. PCT has been shown to be a more accurate marker of infection for some groups of patients.
Prior work on a small number of children shows that PCT increases shortly just from heart surgery itself, even without infection. There is little information published about how accurate PCT is for identifying infection in the child heart population. In order to use PCT in our patients, we need to know what the normal levels of PCT are after surgery. Thus, when an infection does happen, we can identify it. We also need to take PCT levels when patients are thought to have infections. We will then need to watch for an infection over the next few days to see if the PCT level rises and can actually predict the presence an infection.
Goals:
- Determine the Procalcitonin response to cardiopulmonary bypass in children undergoing open-heart surgery. Cardiopulmonary bypass causes a pro-inflammatory state in the patient, and associated rise in Procalcitonin. The ability to use PCT as a marker for infection will require knowledge of its typical response to bypass and the time course to return to baseline.
- Determine the accuracy of Procalcitonin as a marker of infection, and to compare and contrast these findings with currently used laboratory markers.
Specific Aims
- Evaluate PCT in the postoperative pediatric cardiac surgical patient as a marker for infection and sepsis.
- Evaluate PCT's response to cardiopulmonary bypass, and as a predictor of outcome following cardiac surgery.
- Compare PCT to other markers of inflammation and infection (C-reactive protein and white blood cell response).
By doing this study, we hope to find out two things. First, we hope to find out the PCT response to heart surgery in children by taking blood before surgery and each day for four days after surgery. These blood draws will help us figure out the typical PCT response, the normal increase in PCT after heart surgery, and when the PCT level returns to baseline.
Second, we hope to determine the accuracy of PCT as a marker of infection. Whenever we think a patient may have an infection, it is routine care to take some blood and run lab tests such as a white blood cell count, blood culture, and a C-reactive protein level. Patients in the study will also have an additional 10 drops of blood taken for a PCT level at the same time as the routine blood draw. Even though patients may show signs of an infection, the routine blood test do not always come back positive for an infection. We will compare the routine blood test results (positive or negative for an infection) with the PCT level taken at the same time. If most patients with an infection also have a rise in PCT and those patients without an infection have a normal PCT, then we will prove that PCT is a good, accurate marker for infection in our patients.
This research will help us study infection in our patients. It will help distinguish patients with infection, what the risk factors are, how they are treated, and the response to infection. This information will potentially allow us to use an improved test for identifying infection in a high-risk population of children. Patients in the research project will continue to receive the standard of care treatment after heart surgery and there will be no changes in their care during the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study patients will be recruited from Children's Healthcare of Atlanta at Egleston. The patients will be in the pre-operative clinic, Cardiac Intensive Care Unit or the Cardiac Stepdown Unit.
Key inclusion criteria (3 listed)
- Patients with congenital heart disease
- Undergoing cardiopulmonary bypass and cardiac surgery
- Newborn (full term) to up to 6 years of age
Key exclusion criteria (6 listed)
- Premature (less than 37 weeks)
- 6 years of age or older
- Intercurrent illness at time of surgery
- Orthotopic organ transplant recipient
- Pre-operative extra-corporeal support (ECMO)
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
Not reported in the source record.
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 27 Nov 2013.
- Background: PubMed 12700374Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
- Background: PubMed 11445675Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
- Background: PubMed 2055075Hauser GJ, Chan MM, Casey WF, Midgley FM, Holbrook PR. Immune dysfunction in children after corrective surgery for congenital heart disease. Crit Care Med. 1991 Jul;19(7):874-81. doi: 10.1097/00003246-199107000-00009.
- Background: PubMed 1928163Jarvis WR, Edwards JR, Culver DH, Hughes JM, Horan T, Emori TG, Banerjee S, Tolson J, Henderson T, Gaynes RP, et al. Nosocomial infection rates in adult and pediatric intensive care units in the United States. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):185S-191S. doi: 10.1016/0002-9343(91)90367-7.
- Background: PubMed 1642805Mayhall CG. Diagnosis and management of infections of implantable devices used for prolonged venous access. Curr Clin Top Infect Dis. 1992;12:83-110. No abstract available.
- Background: PubMed 14595045Galetto-Lacour A, Zamora SA, Gervaix A. Bedside procalcitonin and C-reactive protein tests in children with fever without localizing signs of infection seen in a referral center. Pediatrics. 2003 Nov;112(5):1054-60. doi: 10.1542/peds.112.5.1054.
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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.
Kevin Maher, MD principal investigator
Emory University
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 Congenital Heart Disease and Sepsis, run by Emory University 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 3 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 27 Nov 2013. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00284570, 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 27 Nov 2013.