Acute Renal Failure (ARF)COVDNCT03013621
Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative
An observational study of Acute Renal Failure (ARF), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery, and is a major risk factor for mortality in this context. The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common complication, close to 100% if one takes into account the transient dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure (ARF)
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jan 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of patients in immediate postoperative period of cardiac surgery, hospitalized in surgical intensive care department
Who may be able to join
- Age: all major patient
- Gender: both
- Subject has signed an informed consent
- IRA KDIGO stage 1 or urine output <0.5 mL / kg / h for at least 6 hours / elevation creat> 26.5μmol / L
- Patient in sinus rhythm at the time of the ultrasound measurements
- No diuretic since intervention
- Absence of circulatory failure (low doses of catecholamines tolerated)
- Extubated: absence of mechanical ventilation
Who cannot join
- Chronic heart failure right
- Chronic renal failure (GFR <60)
- Usual treatment with high dose diuretics (furosemide> 40mg / day)
- Endocarditis
- Emergency surgery (aortic dissection, emergency bypass surgery) / heart surgery D / redux
- Circulatory Support
Show all 12Show fewer
- ACFA / electro-paced rhythm
- Inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...)
- Topic under judicial protection
- Topic guardianship or curatorship
- Pregnancy (women of childbearing age)
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site
Service Réanimation chirurgicale cardio-vasculaire - NHC
Strasbourg, Strasbourg, 67091
Paul-Michel MERTES, MD, PhD, 33 3 69 55 15 78, paul-michel.mertes@chru-strasbourg.fr
Paul-Michel MERTES, MD, PhD
About this study
Official title: Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative (COVD)
Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery, and is a major risk factor for mortality in this context.
The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common complication, close to 100% if one takes into account the transient dysfunction.
A recent study showed that right ventricular dysfunction and the IRA seemed related, rather on the slope of venous congestion. We wish to study this phenomenon more specifically in particular to offer reliable diagnostic markers of venous congestion.
- Conditions
- Acute Renal Failure (ARF)
- Keywords
- Renal Failure, Renal Insufficiency, Acute Renal Failure, Acute Renal Injury, Kidney Failure, Kidney Insufficiency, Acute Kidney Failure, Acute Kidney Injury, Ventricular dysfunction, Venous congestion, Renal function, Kidney function, Venous heart failure
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Ventricular Dysfunction, Hyperemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of sonographic markers of right ventricular
Measured: 1 hour after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal Failure (ARF)Studies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul-Michel MERTES, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013621
- Sponsor's protocol ID
- 6296
- Acronym
- COVD
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative (COVD)
- ClinicalTrials.gov ID
- NCT03013621
- Acronym / sponsor ID
- COVD / 6296
- Conditions
- Acute Renal Failure (ARF)
- Keywords
- Renal Failure, Renal Insufficiency, Acute Renal Failure, Acute Renal Injury, Kidney Failure, Kidney Insufficiency, Acute Kidney Failure, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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 (ARF) is a frequent complication in the postoperative cardiac surgery, and is a major risk factor for mortality in this context.
The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common complication, close to 100% if one takes into account the transient dysfunction.
A recent study showed that right ventricular dysfunction and the IRA seemed related, rather on the slope of venous congestion. We wish to study this phenomenon more specifically in particular to offer reliable diagnostic markers of venous congestion.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients in immediate postoperative period of cardiac surgery, hospitalized in surgical intensive care department
Key inclusion criteria (8 listed)
- Age: all major patient
- Gender: both
- Subject has signed an informed consent
- IRA KDIGO stage 1 or urine output <0.5 mL / kg / h for at least 6 hours / elevation creat> 26.5μmol / L
- Patient in sinus rhythm at the time of the ultrasound measurements
Key exclusion criteria (12 listed)
- Chronic heart failure right
- Chronic renal failure (GFR <60)
- Usual treatment with high dose diuretics (furosemide> 40mg / day)
- Endocarditis
- Emergency surgery (aortic dissection, emergency bypass surgery) / heart surgery D / redux
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of sonographic markers of right ventricular
Time frame: 1 hour after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Paul-Michel MERTES, MD, PhD study director
University Hospital, 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 Acute Renal Failure (ARF), 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 8 inclusion and 12 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 6 Jan 2017. 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?
Contact Paul-Michel MERTES, MD, PhD (33 3 69 55 15 78, paul-michel.mertes@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of sonographic markers of right ventricular (time frame: 1 hour after cardiac surgery). 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 6 Jan 2017.