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Clinical Trials/NCT04062786
NCT04062786
Unknown
Not Applicable

Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

University Hospital, Strasbourg, France1 site in 1 country130 target enrollmentFebruary 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scheduled Heart Surgery
Sponsor
University Hospital, Strasbourg, France
Enrollment
130
Locations
1
Primary Endpoint
Evolution of the gradient Pmsf (arm) -PVC
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2019
End Date
February 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Evolution of the gradient Pmsf (arm) -PVC

Time Frame: 24 hours

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)

Study Sites (1)

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