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

Renal Impairment Clinical Trial

— ECCSTUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405195
• Other study ID #: SahlgrenskaUHThoraxLL0
• Status: Completed
• Start date: October 2011
• Est. completion date: January 2016

Study information

• Verified date: February 2019
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Preserved left ventricular function (LVEF > 50%)

• Normal preoperative S-creatinine

Exclusion Criteria:

• Contraindications to radiocontrast

• Cardiac transplantation och dissection

Related Conditions & MeSH terms

• Complication of Extracorporeal Circulation
• Renal Impairment
• Renal Insufficiency

Intervention

Procedure:
• cardiopulmonary bypass
During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass

Locations

Country	Name	City	State
Sweden	Department of thoracic anesthesia, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Blood Flow (RBF)	Renal blood flow measured with PAH clearance	6 hours
Primary	Glomerular Filtration Rate (GFR)	GFR measured by renal extraction of 51Cr-EDTA	6 hours
Primary	Renal Oxygenation	Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery	6 hours
Secondary	Excretion of NAG	Urinary biomarker of tubular renal injury	24 hours
Secondary	Development of Acute Kidney Injury (AKI)	AKI according to AKIN criteria	72 hours