Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass

NCT ID: NCT01489475

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-06-30

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.

Detailed Description

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.

Conditions

Congenital Heart Defects

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John S Giuliano, Jr, MD

Role: STUDY_DIRECTOR

Yale University

Locations

Yale Children's Hospital

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25258157 (View on PubMed)

Other Identifiers

1107008778

Identifier Type: -

Identifier Source: org_study_id