Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01489475
First received: November 29, 2011
Last updated: October 4, 2013
Last verified: October 2013

November 29, 2011
October 4, 2013
November 2011
June 2013   (final data collection date for primary outcome measure)
  • Change from baseline in pro- and anti-inflammatory protein levels after modified ultrafiltration [ Time Frame: baseline to completion of MUF, on average 2 hours ] [ Designated as safety issue: No ]
    Modified ultrafiltration (MUF) is the process after cardiopulmonary bypass during which a filtration unit is added and blood is filtered and returned back to the patient. The goal of this project is to evaluate the effect of MUF on concentrations of Angiopoietin-2 (Ang-2) and IL 8, two known pro-inflammatory markers involved in capillary leakage, as well as Ang-1 and IL 10, two anti-inflammatory mediators. Levels will be drawn prior to bypass, after MUF and at ICU admission.
  • Change from baseline in pro- and anti-inflammatory protein levels at ICU admission [ Time Frame: baseline to ICU admission, on average 7 hours ] [ Designated as safety issue: No ]
    Modified ultrafiltration (MUF) is the process after cardiopulmonary bypass during which a filtration unit is added and blood is filtered and returned back to the patient. The goal of this project is to evaluate the effect of MUF on concentrations of Angiopoietin-2 (Ang-2) and IL 8, two known pro-inflammatory markers involved in capillary leakage, as well as Ang-1 and IL 10, two anti-inflammatory mediators. Levels will be drawn prior to bypass, after MUF and at ICU admission.
Same as current
Complete list of historical versions of study NCT01489475 on ClinicalTrials.gov Archive Site
  • Biomarker correlation with patient outcome [ Time Frame: Duration of pediatric ICU admission, on average 7 days ] [ Designated as safety issue: No ]
    The biomarkers will be compared to the age of patient, type of surgery performed as well as to post procedure outcome measurements to see if specific protein levels correlate with patient outcomes.
  • Pro- and anti-inflammatory protein presence in ultrafiltration fluid [ Time Frame: Upon MUF completion, on average 2 hours ] [ Designated as safety issue: No ]
    MUF fluid samples will be drawn following bypass. Ang-2, Ang-1, IL-8 and IL-10 levels will be measured to determine if present.
Same as current
Not Provided
Not Provided
 
Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass
Plasma Angiopoietin Levels in Children Undergoing Modified Ultrafiltration Following Cardiopulmonary Bypass

During cardiopulmonary bypass (CPB) after heart surgery, a child's blood is exposed to many foreign entities. These conditions trigger the body's inflammatory response which results in leaky capillaries, increased swelling and possibly organ dysfunction. Since the early 1990's, modified ultrafiltration (MUF) has been shown to decrease excess swelling, reduce bleeding, improve heart function, and decrease hospital length of stay. Angiopoietins are a family of proteins necessary for both normal and abnormal blood vessel formation. They also appear to play a role in capillary leak. Though MUF has been shown to improve clinical outcome following CPB, there continues to be conflicting reports whether this is a result of the filtration of inflammatory proteins or simply from excess fluid removal. Since angiopoietins appear to play a role in both inflammation and capillary leak, the investigators hypothesize that the benefit seen after MUF is also secondary to its ability to filter out these proteins, especially angiopoietin-2.

During cardiopulmonary bypass (CPB) for corrective or palliative congenital heart surgery, a child's blood is subjected to hemodilution, hypothermia, nonpulsatile blood flow and exposure to foreign and non-endothelialized surfaces. These non-physiologic conditions trigger the host's innate systemic inflammatory response which results in capillary leak, increased total body water and can lead to end organ dysfunction. Since the early 1990's, modified ultrafiltration (MUF) has been shown to decrease excess tissue edema, reduce postoperative bleeding, improve cardiac contractility, maintain hemodynamic stability, and decrease hospital length of stay. Angiopoietins are a family of vascular growth factors necessary for both normal and abnormal blood vessel formation and appear to play a role in capillary leak. Though MUF has been shown to improve clinical outcome following CPB, there continues to be conflicting reports whether this is a result of the filtration of inflammatory cytokines or simply excess fluid removal. Since angiopoietins appear to play a role in both inflammation and capillary leak, the investigators aim to determine whether MUF's clinical benefit is also secondary to its ability to filter out these molecules, more specifically angiopoietin-2.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
  1. Modified ultrafiltration fluid
  2. Whole blood which will be spun down to plasma (cells to be discarded)
Non-Probability Sample

Patients with congenital heart disease, undergoing surgical intervention requiring cardiopulmonary bypass and modified ultrafiltration will be recruited.

Congenital Heart Defects
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pediatric patients with congenital heart disease undergoing surgical intervention requiring cardiopulmonary bypass and modified ultrafiltration.

Exclusion Criteria:

  • Any patients with congenital heart disease who will not require modified ultrafiltration.
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01489475
1107008778
No
Yale University
Yale University
Not Provided
Study Director: John S Giuliano, Jr, MD Yale University
Yale University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP