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

Completed

• Conditions: Renal Impairment; Complication of Extracorporeal Circulation

• Registration Number: NCT02405195
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-04-01
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Results First Submitted: 2018-04-27
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-04
• Last Update Submitted: 2019-02-04
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

• Contraindications to radiocontrast
• Cardiac transplantation och dissection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of thoracic anesthesia, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden