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

NCT02672514 | Completed Results

• 1 other identifier: Rölig Studie
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

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

Study Arms (2)

MiECC

ACTIVE COMPARATOR

Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility. CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.

Device: Minimally invasive extracorporeal circulation (MiECC)

CECC

ACTIVE COMPARATOR

Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter. CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.

Device: Conventional extracorporeal circulation (CECC)

Interventions

Minimally invasive extracorporeal circulation (MiECC) DEVICE

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

MiECC

Conventional extracorporeal circulation (CECC) DEVICE

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

CECC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes mellitus type 2
• isolated elective coronary revascularization

You may not qualify if:

• 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

Sponsors & Collaborators

• Herzzentrum Coswig: lead

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

only a single-Center study; a small number of study participants.

Results Point of Contact

• Title: Dr. Jessica Vogler
• Organization: Herzzentrum Coswig

j_vo@web.de

+491749740710

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2015
• Last Updated: March 27, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-02