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

February 4, 2019 updated by: Lukas Lannemyr, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Department of thoracic anesthesia, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elective complex cardiac surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to radiocontrast
  • Cardiac transplantation och dissection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excretion of NAG
Time Frame: 24 hours
Urinary biomarker of tubular renal injury
24 hours
Development of Acute Kidney Injury (AKI)
Time Frame: 72 hours
AKI according to AKIN criteria
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Sven-Erik Ricksten, Professor, Sahlgrenska Academy, dept of clinical science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SahlgrenskaUHThoraxLL0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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