Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative

NCT03013621 | Unknown

• 1 other identifier: 6296
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Renal Failure (ARF)

Keywords

Renal Failure; Renal Insufficiency; Acute Renal Failure; Acute Renal Injury; Kidney Failure; Kidney Insufficiency; Acute Kidney Failure; Acute Kidney Injury; Ventricular dysfunction; Venous congestion; Renal function; Kidney function; Venous heart failure

Outcome Measures

Primary Outcomes (1)

• Quantification of sonographic markers of right ventricular

  1 hour after cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of patients in immediate postoperative period of cardiac surgery, hospitalized in surgical intensive care department

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Réanimation chirurgicale cardio-vasculaire - NHC

Strasbourg, Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency; Ventricular Dysfunction; Hyperemia

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Paul-Michel MERTES, MD, PhD

  University Hospital, Strasbourg, France

  STUDY DIRECTOR

Central Study Contacts

Paul-Michel MERTES, MD, PhD

CONTACT

33 3 69 55 15 78; paul-michel.mertes@chru-strasbourg.fr

Mircea CRISTINAR, MD

CONTACT

33 3 69 55 12 65; mircea.cristinar@chru-strasbourg.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: January 6, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 6, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)