Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?

The aim of this study was to prospectively evaluate MECC compared with conventional extracorporeal circulation of diabetic patients undergoing elective coronary revascularization procedures. The investigators focused on the effects of extracorporeal circulation especially the renal function between both groups.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Cardiopulmonary bypass (CPB) is known having a negative influence referring to systemic inflammatory reaction after cardiac surgery which can cause acute kidney injury (AKI). Miniaturized extracorporeal circulation (MECC) attempts to reduce the adverse effects of conventional extracorporeal circulation bypass. Finally, AKI after CPB is a significant clinical problem that increasingly complicates the course of hospitalization and clinical outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

diabetes mellitus type 2
isolated elective coronary revascularization

Exclusion criteria

urgent or emergent Status
Re-Operation
preexisting reanimation
preexisting renal transplantation
chronic kidney insufficiency (GFR < 30 ml/min)
renal cell carcinoma
renal artery Stenosis
heart valve disease (middle- and high-grade)
endocarditis
infections (HIV, Tbc and all types of Hepatitis)
hepatic cirrhosis

Treatment and study plan

Minimally invasive extracorporeal circulation (MiECC)

Device

Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.

Conventional extracorporeal circulation (CECC)

Device

Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.

Primary outcomes

Acute Kidney Injury

Time frame: within the first 30 days (plus or minus 3 days) after surgery

Sponsors and collaborators

Lead sponsor

Herzzentrum Coswig

Other

Registry information

Official study title

Does Minimal Extracorporeal Circulation Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2015
First posted: Feb 3, 2016
Registry last updated: Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed