Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative

Acute Renal Failure (ARF) Clinical Trial

— COVD  

Official title:

Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative (COVD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03013621
• Other study ID #: 6296
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2016
• Last updated: January 5, 2017
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: August 2016
• Source: University Hospital, Strasbourg, France
• Contact: Paul-Michel MERTES, MD, PhD
• Phone: 33 3 69 55 15 78
• Email: paul-michel.mertes[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery, and is a major risk factor for mortality in this context.

The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common complication, close to 100% if one takes into account the transient dysfunction.

A recent study showed that right ventricular dysfunction and the IRA seemed related, rather on the slope of venous congestion. We wish to study this phenomenon more specifically in particular to offer reliable diagnostic markers of venous congestion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: all major patient

• Gender: both

• Subject has signed an informed consent

• IRA KDIGO stage 1 or urine output <0.5 mL / kg / h for at least 6 hours / elevation creat> 26.5µmol / L

• Patient in sinus rhythm at the time of the ultrasound measurements

• No diuretic since intervention

• Absence of circulatory failure (low doses of catecholamines tolerated)

• Extubated: absence of mechanical ventilation

Exclusion Criteria:

• Chronic heart failure right

• Chronic renal failure (GFR <60)

• Usual treatment with high dose diuretics (furosemide> 40mg / day)

• Endocarditis

• Emergency surgery (aortic dissection, emergency bypass surgery) / heart surgery D / redux

• Circulatory Support

• ACFA / electro-paced rhythm

• Inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...)

• Topic under judicial protection

• Topic guardianship or curatorship

• Pregnancy (women of childbearing age)

• Breastfeeding

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure (ARF)
• Hyperemia
• Renal Insufficiency

Locations

Country	Name	City	State
France	Service Réanimation chirurgicale cardio-vasculaire - NHC	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of sonographic markers of right ventricular		1 hour after cardiac surgery	No