Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

Coronary Artery Bypass Clinical Trial

— PMSF-PVC  

Official title:

Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04062786
• Other study ID #: 7294
• Status: Recruiting
• Start date: February 21, 2019
• Est. completion date: February 2020

Study information

• Verified date: July 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute renal failure is a frequent and severe postoperative complication of cardiac surgery performed under extracorporeal circulation.

It is an independent risk factor for mortality and significantly increases the length of hospital stay.

The origin of renal insufficiency after extracorporeal circulation is multifactorial (long duration of extracorporeal circulation, hemodynamic instability per and post-extracorporeal circulation, prolonged hypotension, transfusion ...).

Nevertheless, an entirely different pathophysiological mechanism, though not recent, is less often mentioned but shows renewed interest. This is the concept of renal venous congestion which may be responsible for impaired renal function in the absence of cardiac dysfunction. Based on Guyton's circulatory model, the investigators approach this systemic venous hypertension through the measurement of the Pmsf-PVC gradient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 2020
• Est. primary completion date: February 21, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age> 18 years

• subject having signed an informed consent

• scheduled heart surgery:

• Valve replacement

• Coronary artery bypass

Exclusion Criteria:

• Any urgent surgery or redux

• Severe preoperative chronic renal failure (stage III) defined by GFR <30ml / min

• Existence of rhythm disorders (permanent ACFA) or serious cardiac conduction disorders, patients with Pacemaker

• Preoperative alteration of left ventricular ejection fraction with LVEF <40%

• Major haemodynamic instability with refractory shock defined by dobutamine =10µg / kg / min and / or norepinephrine = 1µg / kg / min and / or epinephrine = 0.2µg / kg / min.

• Intra-aortic versus assisted pelvic balloon

• Contraindication to femoral arterial catheterization

• Subject under the protection of justice, subject under guardianship or under tutorship

• Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Renal Insufficiency
• Scheduled Heart Surgery
• Valve Replacement

Intervention

Other:
• Pmsf-PVC gradient measurement
implementation of standard standard hemodynamic monitorin

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	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	Evolution of the gradient Pmsf (arm) -PVC	Monitor the evolution of the Pmsf (arm) -PVC gradient at H24 and compare this gradient between the two patient populations (with and without postoperative acute renal failure)	24 hours