Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass

NCT01489475 | Completed

• 1 other identifier: 1107008778
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Defects

Keywords

children; congenital heart defects; cardiopulmonary bypass; modified ultrafiltration; angiopoietins; cytokines

Outcome Measures

Primary Outcomes (2)

• Change from baseline in pro- and anti-inflammatory protein levels after modified ultrafiltration

  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.

  baseline to completion of MUF, on average 2 hours

• Change from baseline in pro- and anti-inflammatory protein levels at ICU admission

  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.

  baseline to ICU admission, on average 7 hours

Secondary Outcomes (2)

• Biomarker correlation with patient outcome

  Duration of pediatric ICU admission, on average 7 days

• Pro- and anti-inflammatory protein presence in ultrafiltration fluid

  Upon MUF completion, on average 2 hours

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Any patients with congenital heart disease who will not require modified ultrafiltration.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Children's Hospital

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• Lang SM, Syed MA, Dziura J, Rocco E, Kirshbom P, Bhandari V, Giuliano JS Jr. The effect of modified ultrafiltration on angiopoietins in pediatric cardiothoracic operations. Ann Thorac Surg. 2014 Nov;98(5):1699-704. doi: 10.1016/j.athoracsur.2014.06.053. Epub 2014 Sep 23.

  PMID: 25258157 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

1. Modified ultrafiltration fluid 2. Whole blood which will be spun down to plasma (cells to be discarded)

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• John S Giuliano, Jr, MD

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 9, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 26, 2015

Record last verified: 2013-10

Locations

US (1)