Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

NCT04062786 | Unknown

• 1 other identifier: 7294
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scheduled Heart Surgery; Valve Replacement; Coronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Pmsf-PVC gradient measurement OTHER

implementation of standard standard hemodynamic monitorin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major patient with scheduled heart surgery

You may qualify if:

• age\> 18 years
• subject having signed an informed consent
• scheduled heart surgery:
• Valve replacement
• Coronary artery bypass

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 20, 2019
• Study Start: February 21, 2019
• Primary Completion: February 21, 2019
• Study Completion: February 1, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-07

Locations

FR (1)