Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study (PMSF-PVC)

August 19, 2019 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Les Hopitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Bob HEGER
        • Sub-Investigator:
          • Paul Michel MERTES
        • Sub-Investigator:
          • Annick STEIB
        • Sub-Investigator:
          • Michel KINDO
        • Sub-Investigator:
          • Gharib AJOB
        • Sub-Investigator:
          • Mircea CRISTINAR
        • Sub-Investigator:
          • Sandrine MARGUERITE
        • Sub-Investigator:
          • Walid OULEHRI
        • Sub-Investigator:
          • Francois LEVY
        • Sub-Investigator:
          • François FISCHER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Major patient with scheduled heart surgery

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2019

Primary Completion (Actual)

February 21, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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