Complication of Extracorporeal CirculationECCSTUDNCT02405195

Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)

An observational study of Complication of Extracorporeal Circulation and Renal Impairment, run by Sahlgrenska University Hospital at 1 site in Sweden.

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

Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Complication of Extracorporeal Circulation, Renal Impairment
What is being tested?: cardiopulmonary bypass
Type of treatment: Surgery or procedure
How many people: 28 participants
Where: 1 siteSweden
Study dates: Oct 2011to Jan 2016
Phase: Observational
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Elective complex cardiac surgery

Who may be able to join

Preserved left ventricular function (LVEF > 50%)
Normal preoperative S-creatinine

Who cannot join

Contraindications to radiocontrast
Cardiac transplantation och dissection

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Department of thoracic anesthesia, Sahlgrenska University Hospital
Gothenburg, 41345

Other trials in Sweden

About this study

Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.

Read the detailed description

After approval of the regional ethics committee, patients (n=16) undergoing combined cardiac surgery procedures during normothermic CPB will be included after informed consent. Systemic and renal variables will be measured by pulmonary artery and renal vein catheters. Glomerular filtration rate (GFR) will be measured by renal extraction of 51Cr-EDTA and renal blood flow (RBF) by the infusion clearance technique for para-aminohippuric acid (PAH) corrected for by renal extraction of PAH. Repeated measures ANOVA followed by Fisher's PLSD post-hoc test were used for statistical analyses

Conditions: Complication of Extracorporeal Circulation, Renal Impairment
Being tested: cardiopulmonary bypass
Medical subject headings: Renal Insufficiency

What participants receive

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

cardiopulmonary bypassProcedure or surgery
Also called extracorporeal circulation
During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass

What is being measured

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

Renal Blood Flow (RBF)
Renal blood flow measured with PAH clearance
Measured: 6 hours
Glomerular Filtration Rate (GFR)
GFR measured by renal extraction of 51Cr-EDTA
Measured: 6 hours
Renal Oxygenation
Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery
Measured: 6 hours

Secondary outcomes (2)

Excretion of NAG
Urinary biomarker of tubular renal injury
Measured: 24 hours
Development of Acute Kidney Injury (AKI)
AKI according to AKIN criteria
Measured: 72 hours

Timeline

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

Oct 2011Jan 2016

First posted1 Apr 2015 (estimated)
Study startOct 2011
Primary completionDec 2015
Study completionJan 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Complication of Extracorporeal CirculationStudies of the same condition, open and under way.
More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02405195
Sponsor's protocol ID: SahlgrenskaUHThoraxLL0
Acronym: ECCSTUD
Status last verified: Feb 2019
First submitted: 27 Mar 2015
Last updated: 7 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lannemyr L, Bragadottir G, Redfors B, Ricksten SE. Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery. J Crit Care. 2020 Jun;57:225-230. doi: 10.1016/j.jcrc.2019.12.022. Epub 2020 Jan 6.
PubMed 31919012

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?

See locations

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Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
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All Complication of Extracorporeal Circulation trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)
ClinicalTrials.gov ID: NCT02405195
Acronym / sponsor ID: ECCSTUD / SahlgrenskaUHThoraxLL0
Conditions: Complication of Extracorporeal Circulation, Renal Impairment
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Sahlgrenska University HospitalUniversity, hospital or other
Study start: Oct 2011
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 1 Apr 2015 (estimated)
Results: Posted 7 May 2019

Clinical summary

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

Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Elective complex cardiac surgery

Key inclusion criteria (2 listed)

Preserved left ventricular function (LVEF > 50%)
Normal preoperative S-creatinine

Key exclusion criteria (2 listed)

Contraindications to radiocontrast
Cardiac transplantation och dissection

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
cardiopulmonary bypassAlso: extracorporeal circulationDuring cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass	Procedure or surgery	–

Primary outcome

Renal Blood Flow (RBF)
Time frame: 6 hours
Renal blood flow measured with PAH clearance
Glomerular Filtration Rate (GFR)
Time frame: 6 hours
GFR measured by renal extraction of 51Cr-EDTA
Renal Oxygenation
Time frame: 6 hours
Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery

2 secondary outcomes

Excretion of NAG
Time frame: 24 hours
Development of Acute Kidney Injury (AKI)
Time frame: 72 hours

Results and safety

Results posted to the registry on 7 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CardioPulmonaryBypass	18	18

Primary outcome: Renal Blood Flow (RBF)

Time frame: 6 hours. Mean (Standard Deviation). Unit: ml per minute per 1.73 m2 body surface

Measure	CardioPulmonaryBypass n = 18
Pre CPB	554 (126)
CPB 30 minutes	524 (116)
CPB 60 minutes	564 (162)
Post CPB (30 - 60 minutes)	558 (130)

CardioPulmonaryBypass: p = 0.638, ANOVA

Primary outcome: Glomerular Filtration Rate (GFR)

Time frame: 6 hours. Mean (Standard Deviation). Unit: ml per minute per 1.73 m2 body surface

Measure	CardioPulmonaryBypass n = 18
Before CPB	67 (23)
CPB 30 minutes	68 (23)
CPB 60 minutes	70 (19)
Post CPB (30 - 60 minutes)	67 (18)

CardioPulmonaryBypass: p = 0.972, ANOVA

Primary outcome: Renal Oxygenation

Time frame: 6 hours. Mean (Standard Deviation). Unit: fraction

Measure	CardioPulmonaryBypass n = 18
Pre CPB	0.09 (0.03)
CPB 30 minutes	0.12 (0.05)
CPB 60 minutes	0.13 (0.06)
Post CPB (30 - 60 minutes)	0.16 (0.05)

CardioPulmonaryBypass: p <0.001, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Three days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CardioPulmonaryBypass	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31919012Lannemyr L, Bragadottir G, Redfors B, Ricksten SE. Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery. J Crit Care. 2020 Jun;57:225-230. doi: 10.1016/j.jcrc.2019.12.022. Epub 2020 Jan 6.

Related trials for Complication of Extracorporeal Circulation

RecruitingObservational study
Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG)
Blood Platelet Disorders, Cardiac Surgery
Active, not recruitingObservational study
Effect of Minimally Invasive Extracorporeal Circulation on Optic Nerve Sheath Diameter and Stroke Incidence in Isolated Open Heart Surgery
Stroke, Cardiac Surgery
Active, not recruitingPhase 3
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome
RecruitingObservational study
Evaluation of Blood and Cardiac Protein O-GlcNAcylation Levels in Cardiac Surgery in Children
Cardiac Surgery, Extracorporeal Circulation; Complications
RecruitingObservational study
A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass
Cardiac Diseases, Cardio-pulmonary Bypass

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.

Sven-Erik Ricksten, Professor principal investigator

Sahlgrenska Academy, dept of clinical science

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Complication of Extracorporeal Circulation and Renal Impairment, run by Sahlgrenska University Hospital at 1 site in Sweden.

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 2 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

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 7 May 2019). 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?

Renal Blood Flow (RBF) (time frame: 6 hours). The study lists 3 primary outcomes in all. 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 NCT02405195, which also lists 1 linked publication.

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 7 May 2019.