Congenital Heart DefectProCardNCT03143348
Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass
An observational study of Congenital Heart Defect and Cardiopulmonary Bypass, run by University of Oklahoma at 1 site in United States.
Trial summary
This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Congenital Heart Defect, Cardiopulmonary Bypass, Inflammatory Response
- What is being tested?
- Single blood draw and Multiple blood draws
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2017to 15 Apr 2019
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants <6 months of age with congenital heart disease at OU Children's Hospital
Who may be able to join
- Infants < 6 months of age
- Born at ≥ 36 weeks gestational age
- Birth weight ≥ 2.5 kilograms
- Postnatally confirmed congenital heart disease by echocardiogram
Who cannot join
- Requiring ≥ 2 vasopressors prior to surgery
- Preoperative proven sepsis within one week of surgery
- Prior surgery within one week of cardiac repair (except PA banding which is not excluded)
- Cardiac catheterization within one week of surgery
- Significant extra-cardiac anomalies that may impair organ function
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass (ProCard): an Observational Pilot Study
This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Additionally, the investigators want to examine if these markers can predict which babies develop post-surgical complications. The hypothesis is that babies who undergo bypass will have higher levels of these markers than babies not exposed to bypass and that these markers will correlate with how the baby does clinically after surgery.
This study will evaluate markers via blood sampling in babies with congenital heart disease who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that undergo surgery with bypass. The overall goal is that this study will lead to useful biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for babies who require heart-lung bypass.
Read the detailed description
This is a minimal risk observational study looking at markers of inflammation and cell injury in the bloodstream of babies with congenital heart disease, with a particular emphasis on whether these markers can predict low cardiac output syndrome in infants who undergo heart-lung bypass. Low cardiac output syndrome is a common postoperative complication marked by poor blood flow to the body affecting nearly 1/3 of infants post-bypass and is associated with significant morbidity and mortality.
Babies not requiring surgery will serve as the control group. Infants in group 1 will have 0.5 ml of blood drawn prior to discharge. This will be scavenged from the laboratory when possible. Infants in groups 2 and 3 will require serial blood draws over peri-operative time points each in the volume of 0.5 ml.
Group 2:
T0 = Before surgery (in the OR) T1 = After chest closure or end of case (in the OR) T2 = On admission to the pediatric intensive care unit T3 = Timed 4-6 hours after the time of admission T4 = Timed 12 hours (+/- 1 hour) after the time of admission T5 = Timed 24 hours (+/-1 hour) after the time of admission
Group 3:
T0 =Pre-cardiopulmonary bypass to be obtained in the operating room just prior to surgery T1 = After going on bypass (but prior to modified ultrafiltration) T2 = After modified ultrafiltration T3 = On admission to the pediatric intensive care unit T4 = Timed 4-6 hours after the time of admission T5 = Timed 12 hours (+/- 1 hour) after the time of admission T6 = Timed 24 hours (+/-1 hour) after the time of admission
- Conditions
- Congenital Heart Defect, Cardiopulmonary Bypass, Inflammatory Response, Low Cardiac Output Syndrome, Inflammation
- Being tested
- Single blood draw, Multiple blood draws
- Medical subject headings
- Heart Defects, Congenital, Cardiac Output, Low, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single blood drawProcedure or surgery
One blood draw of 0.5 ml volume prior to discharge
Multiple blood drawsProcedure or surgery
Blood draw at 6 peri-operative time points.
Multiple blood drawsProcedure or surgery
Blood draw at 7 peri-operative time points
| Study group | Role | What they receive |
|---|---|---|
| Control/Nonsurgical | Infants with postnatally confirmed acyanotic congenital heart disease not expected to require surgery in the first six months of life. Receives: Procedure: Single blood draw | |
| Surgery w/o bypass | Infants with postnatally confirmed congenital heart disease requiring cardiac surgery without cardiopulmonary bypass. Receives: Procedure: Multiple blood draws | |
| Surgery w/ bypass | Infants with postnatally confirmed congenital heart disease requiring cardiac surgery with cardiopulmonary bypass. Receives: Procedure: Multiple blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker levels and their relationship to LCOS
Changes in markers of inflammation and cell injury (histones, IL-6, etc.) and correlation with patients who develop low cardiac output syndrome
Measured: Baseline level and described time points over the first twenty-four hours postoperatively
Secondary outcomes (9)
Change in level of inflammatory response
Changes in markers of inflammation and cell injury (IL-6, IL-8, etc.) in the peri-operative period (prior to surgery up to 24 hours postop)
Measured: Baseline, up to 24 hours
Length of mechanical ventilation
Number of days on mechanical ventilation following day of surgery until the point of extubation
Measured: Participants will be followed throughout hospital course, maximum length of follow-up one year
Acute kidney injury
Doubling of creatinine in first twenty four hours compared to preoperative levels
Measured: Participants will be followed for the first twenty four hours postoperatively
Extracorporeal membrane oxygenation (ECMO)
Whether or not patient requires ECMO cannulation
Measured: First 48 hours postoperatively
ICU length of stay
Number of days requiring pediatric/cardiac intensive care unit following day of surgery
Measured: Participants will be followed throughout PICU/CVICU stay, maximum length of follow-up one year
Hospital length of stay
Number of hospital days patient requires following the day of surgery
Measured: Participants will be followed throughout entire hospital course, maximum length of follow-up one year
Mortality risk
Pediatric risk of mortality-3 scale (PRISM-3) and pediatric index of mortality (PIM-2)
Measured: PIM-2 calculated within one hour of admission to PICU and PRISM-3 calculated at 12 and 24 hours after PICU admission
Mortality
Any type of death that occurs during patient's hospitalization
Measured: Participants will be followed throughout hospital course, maximum length of follow-up one year
Low cardiac output syndrome
At least two of the following criteria at any post-operative time point within the first twenty four hours: (a) prolonged cap refill >3 sec, SBP <5th %ile for age and gender, low UOP <1 cc/kg/hr for at least 6 hr not responsive to diuretics, persistently elevated arterial lactate >2 and metabolic acidosis defined as an increase in the base deficit of >4, inotropic score >20, cardiac arrest within 48 hr after surgery, or the need for extracorporeal membrane oxygenation (ECMO) for hemodynamic instability within 48 hours postop
Measured: Assessed at 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start4 Jun 2017
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hala Chaaban, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143348
- Sponsor's protocol ID
- 7676
- Acronym
- ProCard
- Status last verified
- Apr 2019
- First submitted
- 13 Mar 2017
- Last updated
- 30 Apr 2019
- 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 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass (ProCard): an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT03143348
- Acronym / sponsor ID
- ProCard / 7676
- Conditions
- Congenital Heart Defect, Cardiopulmonary Bypass, Inflammatory Response, Low Cardiac Output Syndrome, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 4 Jun 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 8 May 2017 (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.
This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Additionally, the investigators want to examine if these markers can predict which babies develop post-surgical complications. The hypothesis is that babies who undergo bypass will have higher levels of these markers than babies not exposed to bypass and that these markers will correlate with how the baby does clinically after surgery.
This study will evaluate markers via blood sampling in babies with congenital heart disease who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that undergo surgery with bypass. The overall goal is that this study will lead to useful biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for babies who require heart-lung bypass.
Detailed description
This is a minimal risk observational study looking at markers of inflammation and cell injury in the bloodstream of babies with congenital heart disease, with a particular emphasis on whether these markers can predict low cardiac output syndrome in infants who undergo heart-lung bypass. Low cardiac output syndrome is a common postoperative complication marked by poor blood flow to the body affecting nearly 1/3 of infants post-bypass and is associated with significant morbidity and mortality.
Babies not requiring surgery will serve as the control group. Infants in group 1 will have 0.5 ml of blood drawn prior to discharge. This will be scavenged from the laboratory when possible. Infants in groups 2 and 3 will require serial blood draws over peri-operative time points each in the volume of 0.5 ml.
Group 2:
T0 = Before surgery (in the OR) T1 = After chest closure or end of case (in the OR) T2 = On admission to the pediatric intensive care unit T3 = Timed 4-6 hours after the time of admission T4 = Timed 12 hours (+/- 1 hour) after the time of admission T5 = Timed 24 hours (+/-1 hour) after the time of admission
Group 3:
T0 =Pre-cardiopulmonary bypass to be obtained in the operating room just prior to surgery T1 = After going on bypass (but prior to modified ultrafiltration) T2 = After modified ultrafiltration T3 = On admission to the pediatric intensive care unit T4 = Timed 4-6 hours after the time of admission T5 = Timed 12 hours (+/- 1 hour) after the time of admission T6 = Timed 24 hours (+/-1 hour) after the time of admission
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control/Nonsurgical | – | Procedure: Single blood drawInfants with postnatally confirmed acyanotic congenital heart disease not expected to require surgery in the first six months of life. |
| Surgery w/o bypass | – | Procedure: Multiple blood drawsInfants with postnatally confirmed congenital heart disease requiring cardiac surgery without cardiopulmonary bypass. |
| Surgery w/ bypass | – | Procedure: Multiple blood drawsInfants with postnatally confirmed congenital heart disease requiring cardiac surgery with cardiopulmonary bypass. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants <6 months of age with congenital heart disease at OU Children's Hospital
Key inclusion criteria (4 listed)
- Infants < 6 months of age
- Born at ≥ 36 weeks gestational age
- Birth weight ≥ 2.5 kilograms
- Postnatally confirmed congenital heart disease by echocardiogram
Key exclusion criteria (5 listed)
- Requiring ≥ 2 vasopressors prior to surgery
- Preoperative proven sepsis within one week of surgery
- Prior surgery within one week of cardiac repair (except PA banding which is not excluded)
- Cardiac catheterization within one week of surgery
- Significant extra-cardiac anomalies that may impair organ function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single blood drawOne blood draw of 0.5 ml volume prior to discharge | Procedure or surgery | Control/Nonsurgical |
| Multiple blood drawsBlood draw at 6 peri-operative time points. | Procedure or surgery | Surgery w/o bypass |
| Multiple blood drawsBlood draw at 7 peri-operative time points | Procedure or surgery | Surgery w/ bypass |
Primary outcome
Biomarker levels and their relationship to LCOS
Time frame: Baseline level and described time points over the first twenty-four hours postoperatively
Changes in markers of inflammation and cell injury (histones, IL-6, etc.) and correlation with patients who develop low cardiac output syndrome
9 secondary outcomes
Change in level of inflammatory response
Time frame: Baseline, up to 24 hours
Length of mechanical ventilation
Time frame: Participants will be followed throughout hospital course, maximum length of follow-up one year
Acute kidney injury
Time frame: Participants will be followed for the first twenty four hours postoperatively
Extracorporeal membrane oxygenation (ECMO)
Time frame: First 48 hours postoperatively
ICU length of stay
Time frame: Participants will be followed throughout PICU/CVICU stay, maximum length of follow-up one year
Hospital length of stay
Time frame: Participants will be followed throughout entire hospital course, maximum length of follow-up one year
Mortality risk
Time frame: PIM-2 calculated within one hour of admission to PICU and PRISM-3 calculated at 12 and 24 hours after PICU admission
Mortality
Time frame: Participants will be followed throughout hospital course, maximum length of follow-up one year
Low cardiac output syndrome
Time frame: Assessed at 48 hours postoperatively
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 30 Apr 2019.
- 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.
Hala Chaaban, MD principal investigator
University of Oklahoma
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 Defect and Cardiopulmonary Bypass, run by University of Oklahoma 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 4 inclusion and 5 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 30 Apr 2019. 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?
Biomarker levels and their relationship to LCOS (time frame: Baseline level and described time points over the first twenty-four hours postoperatively). 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 30 Apr 2019.