Preoperative KIDNEY FAILURE, CHRONICNGAL-CKFNCT01227122
NGAL Predictive Value of Acute Kidney Failure After Cardiac Surgery in Patients With Preoperative Chronic Kidney Failure
An observational study of Preoperative KIDNEY FAILURE, CHRONIC and Postoperative KIDNEY FAILURE, ACUTE, run by Hopital Jean Minjoz at 1 site in France.
Trial summary
Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative KIDNEY FAILURE, CHRONIC, Postoperative KIDNEY FAILURE, ACUTE, Cardiac Surgical Procedures
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2010to Sep 2013
- 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: Patients with a chronic kidney failure, undergoing cardiac surgery.
Who may be able to join
- Renal clearance less than 60 mL/min
- Able to give written consent
- Elective valve surgery
- Elective CABG surgery
Who cannot join
- Less than 18 years old
- Iodine injection within 3 days before surgery
- Iodine injection within 24 first postoperative hours
- preoperative infection
- evolutive cancer disease
- Refusal
- Pregnancy
- Unable to give written consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier Universitaire (CHU) Jean Minjoz
Besançon, Franche-Comté, 25000
CHOCRON Sidney, MD, PhD, +33381668662, sidney.chocron@univ-fcomte.fr
Chocron Sidney, MD, PhD
About this study
Official title: Plasmatic Level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a Predictive Marker of Acute Kidney Failure in Patients With Preoperative Chronic Kidney Failure Undergoing Cardiac Surgery.
Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL.
Read the detailed description
(N/A)
- Conditions
- Preoperative KIDNEY FAILURE, CHRONIC, Postoperative KIDNEY FAILURE, ACUTE, Cardiac Surgical Procedures
- Keywords
- NGAL plasmatic level, Preoperative KIDNEY FAILURE, CHRONIC, Postoperative KIDNEY FAILURE, ACUTE, Cardiac Surgery Procedures
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil Gelatinase Associated Lipocalin (NGAL) level
Measured: From surgery to discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative KIDNEY FAILURE, CHRONICStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Jean Minjoz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sidney Chocron, Hopital Jean Minjoz
- Investigators
- Chocron Sidney, MD, PhD, Principal investigator, Centre Hospitalier Universitaire (CHU) Jean Minjoz, Besançon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227122
- Sponsor's protocol ID
- 2010-A00111-38
- Acronym
- NGAL-CKF
- Status last verified
- Mar 2013
- First submitted
- 22 Oct 2010
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasmatic Level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a Predictive Marker of Acute Kidney Failure in Patients With Preoperative Chronic Kidney Failure Undergoing Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT01227122
- Acronym / sponsor ID
- NGAL-CKF / 2010-A00111-38
- Conditions
- Preoperative KIDNEY FAILURE, CHRONIC, Postoperative KIDNEY FAILURE, ACUTE, Cardiac Surgical Procedures
- Keywords
- NGAL plasmatic level, Preoperative KIDNEY FAILURE, CHRONIC, Postoperative KIDNEY FAILURE, ACUTE, Cardiac Surgery Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hopital Jean MinjozUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 25 Oct 2010 (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.
Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL.
Detailed description
(N/A)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a chronic kidney failure, undergoing cardiac surgery.
Key inclusion criteria (4 listed)
- Renal clearance less than 60 mL/min
- Able to give written consent
- Elective valve surgery
- Elective CABG surgery
Key exclusion criteria (8 listed)
- Less than 18 years old
- Iodine injection within 3 days before surgery
- Iodine injection within 24 first postoperative hours
- preoperative infection
- evolutive cancer disease
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
Neutrophil Gelatinase Associated Lipocalin (NGAL) level
Time frame: From surgery to discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
Related trials for Preoperative KIDNEY FAILURE, CHRONIC
Recruiting
Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial
Perioperative Management, End Stage Kidney Disease (ESRD)
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.
Centre hospitalier Universitaire (CHU) Jean Minjoz
Besançon, France
Chocron Sidney, MD, PhD principal investigator
Centre Hospitalier Universitaire (CHU) Jean Minjoz, Besançon, 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 Preoperative KIDNEY FAILURE, CHRONIC and Postoperative KIDNEY FAILURE, ACUTE, run by Hopital Jean Minjoz 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 4 inclusion and 8 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 4 Mar 2013. 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?
Neutrophil Gelatinase Associated Lipocalin (NGAL) level (time frame: From surgery to discharge from hospital). 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 4 Mar 2013.