Cardiac SurgeryNCT01594788
Neutrophil Gelatinase-associated Lipocalin as a New Biomarker to Detect Acute Kidney Injury in Postoperative Cardiac Surgery
An observational study of Cardiac Surgery, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 340 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Dec 2012
- 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: Hospitalised patients
Who may be able to join
- Men or women over 18 years proposed for cardiac surgery with / without CPB.
- Accepting to participate in the study, with informed consent signed by the patient, guardian or family member.
Who cannot join
- Patients < 18 years.
- Patients do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Mercedes Garcia, MD, +34 93 553 75 41, mgarciaa@santpau.cat
Mercedes Garcia, MD
About this study
Official title: NGAL as a Marker of Acute Kidney Injury After Cardiac Surgery. Observational Study
Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB).
- Conditions
- Cardiac Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- 340 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594788
- Sponsor's protocol ID
- IIBSP-NGL-2011-04
- Status last verified
- Jan 2012
- First submitted
- 7 May 2012
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NGAL as a Marker of Acute Kidney Injury After Cardiac Surgery. Observational Study
- ClinicalTrials.gov ID
- NCT01594788
- Acronym / sponsor ID
- IIBSP-NGL-2011-04
- Conditions
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Apr 2011
- Study completion
- Dec 2012
- First posted
- 9 May 2012 (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.
Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalised patients
Key inclusion criteria (2 listed)
- Men or women over 18 years proposed for cardiac surgery with / without CPB.
- Accepting to participate in the study, with informed consent signed by the patient, guardian or family member.
Key exclusion criteria (2 listed)
- Patients < 18 years.
- Patients do not agree to participate in the study.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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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.
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 Cardiac Surgery, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 2 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 9 May 2012. 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 Spain. 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 Mercedes Garcia, MD (+34 93 553 75 41, mgarciaa@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 May 2012.