Scheduled Heart SurgeryPMSF-PVCNCT04062786
Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study
An observational study of Scheduled Heart Surgery and Valve Replacement, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scheduled Heart Surgery, Valve Replacement, Coronary Artery Bypass
- What is being tested?
- Pmsf-PVC gradient measurement
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2019to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major patient with scheduled heart surgery
Who may be able to join
- age> 18 years
- subject having signed an informed consent
- scheduled heart surgery:
- Valve replacement
- Coronary artery bypass
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Bob HEGER, +33 03 69 55 04 44, Bob.heger@chru-strasbourg.fr
Bob HEGER
About this study
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.
Read more
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.
- Being tested
- Pmsf-PVC gradient measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pmsf-PVC gradient measurementOther
implementation of standard standard hemodynamic monitorin
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start21 Feb 2019
- Primary completion21 Feb 2019
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scheduled Heart SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062786
- Sponsor's protocol ID
- 7294
- Acronym
- PMSF-PVC
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study
- ClinicalTrials.gov ID
- NCT04062786
- Acronym / sponsor ID
- PMSF-PVC / 7294
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major patient with scheduled heart surgery
Key inclusion criteria (5 listed)
- age> 18 years
- subject having signed an informed consent
- scheduled heart surgery:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pmsf-PVC gradient measurementimplementation of standard standard hemodynamic monitorin | Other | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scheduled Heart Surgery and Valve Replacement, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the gradient Pmsf (arm) -PVC (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.