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Completed

NCT Number: NCT02405195

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

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.

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Key information

Conditions

Complication of Extracorporeal Circulation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to radiocontrast
  • Cardiac transplantation och dissection

Treatment and study plan

cardiopulmonary bypass

Procedure

During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass

Other names: extracorporeal circulation

Primary outcomes

  1. Renal Blood Flow (RBF)

    Time frame: 6 hours

    Renal blood flow measured with PAH clearance

  2. Glomerular Filtration Rate (GFR)

    Time frame: 6 hours

    GFR measured by renal extraction of 51Cr-EDTA

  3. Renal Oxygenation

    Time frame: 6 hours

    Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery

Secondary outcomes

  1. Excretion of NAG

    Time frame: 24 hours

    Urinary biomarker of tubular renal injury

  2. Development of Acute Kidney Injury (AKI)

    Time frame: 72 hours

    AKI according to AKIN criteria

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: ECCSTUD

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Apr 1, 2015
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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