Acute Kidney InjuryNCT02672514

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

A study testing Minimally invasive extracorporeal circulation (MiECC) and Conventional extracorporeal circulation (CECC) in people with Acute Kidney Injury, run by Herzzentrum Coswig.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Kidney Injury
What is being tested?: Minimally invasive extracorporeal circulation (MiECC) and Conventional extracorporeal circulation (CECC)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: No sites listed yet
Study dates: Feb 2010to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diabetes mellitus type 2
isolated elective coronary revascularization

Who cannot join

urgent or emergent Status
Re-Operation
preexisting reanimation
preexisting renal transplantation
chronic kidney insufficiency (GFR < 30 ml/min)
renal cell carcinoma

Show all 11Show fewer

renal artery Stenosis
heart valve disease (middle- and high-grade)
endocarditis
infections (HIV, Tbc and all types of Hepatitis)
hepatic cirrhosis

About this study

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

Read the detailed 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.

Conditions: Acute Kidney Injury
Being tested: Minimally invasive extracorporeal circulation (MiECC), Conventional extracorporeal circulation (CECC)
Medical subject headings: Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02672514
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Conventional extracorporeal circulation (CECC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute Kidney Injury
Measured: within the first 30 days (plus or minus 3 days) after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Jun 2015

First posted3 Feb 2016 (estimated)
Study startFeb 2010
Primary completionApr 2012
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02672514
Sponsor's protocol ID: Rölig Studie
Status last verified: Feb 2017
First submitted: 19 Jan 2016
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Acute Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Minimal Extracorporeal Circulation Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
ClinicalTrials.gov ID: NCT02672514
Acronym / sponsor ID: Rölig Studie
Conditions: Acute Kidney Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Herzzentrum CoswigUniversity, hospital or other
Study start: Feb 2010
Primary completion: Apr 2012 (actual)
Study completion: Jun 2015 (actual)
First posted: 3 Feb 2016 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
MiECC	Active comparator	Device: Minimally invasive extracorporeal circulation (MiECC)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.
CECC	Active comparator	Device: Conventional extracorporeal circulation (CECC)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

diabetes mellitus type 2
isolated elective coronary revascularization

Key exclusion criteria (11 listed)

urgent or emergent Status
Re-Operation
preexisting reanimation
preexisting renal transplantation
chronic kidney insufficiency (GFR < 30 ml/min)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Minimally invasive extracorporeal circulation (MiECC)Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.	Device	MiECC
Conventional extracorporeal circulation (CECC)Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.	Device	CECC

Primary outcome

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

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MiECC	53	53
CECC	51	51

Primary outcome: Acute Kidney Injury

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

Measure	Group B n = 53	Group A n = 51
direct after operation	7	41
1 hour after operation	9	40

Group B vs Group A: p = 0.377, Wilcoxon (Mann-Whitney)
Group B vs Group A: p = 0.051, Wilcoxon (Mann-Whitney)
Group B vs Group A: p = 0.282, Wilcoxon (Mann-Whitney)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MiECC	12 of 53 (22.6%)	0 of 53 (0%)	Not reported
CECC	7 of 51 (13.7%)	1 of 51 (2%)	Not reported

Limitations and caveats (from the sponsor): only a single-Center study; a small number of study participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Kidney Injury

Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Minimally invasive extracorporeal circulation (MiECC) and Conventional extracorporeal circulation (CECC) in people with Acute Kidney Injury, run by Herzzentrum Coswig.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Kidney Injury (time frame: within the first 30 days (plus or minus 3 days) after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02672514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.