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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672514
• Other study ID #: Rölig Studie
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: February 1, 2016
• Start date: February 2010
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Herzzentrum Coswig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2015
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Device:
• Minimally invasive extracorporeal circulation (MiECC)
Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
• Conventional extracorporeal circulation (CECC)
Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Herzzentrum Coswig

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury		within the first 30 days (plus or minus 3 days) after surgery	Yes