Contrast Media Induced Nephropathy (CIN)NCT01292317
Neutrophil Gelatinase-associated Lipocalin (NGAL) and Contrast Media Induced Nephropathy
A study testing application of intravenous volume and oral fluid application in people with Contrast Media Induced Nephropathy (CIN), run by Medical University of Graz at 1 site in Austria.
Trial summary
Introduction: Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker predictive for acute renal injury has been shown to be capable for earlier diagnosis of acute contrast media induced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Media Induced Nephropathy (CIN)
- What is being tested?
- application of intravenous volume and oral fluid application
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 819 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- Patients with the need for intra-arterial angiography/angioplasty
- Patients older than 18 years
- Patients with clinically stable chronic renal insufficiency stage 2 and more (calculated GFR < 70 ml/min/1,73 m2)(65)
- Written informed consent
Who cannot join
- Pre-existing clinical and/or laboratory evidence of acute renal failure at the time of enrollment
- Evidence of rhabdomyolysis
- Patients on renal replacement therapy (34)
- Patients with life-threatening underlying disease (sepsis, MOF, SIRS)
- Contraindication for volume therapy
- Pregnancy
- Contrast media application within 7 days prior to intervention
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Medicine, Division of Nephrology
Graz, Styria, 8036
About this study
Official title: Early Detection and Intervention of Acute Contrast Media Induced Nephropathy Using Neutrophil Gelatinase-associated Lipocalin (NGAL) May Improve Renal Outcome: A Study in Patients Undergoing Intra-arterial Angiography.
Introduction:
Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker predictive for acute renal injury has been shown to be capable for earlier diagnosis of acute contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.
Read more
Intravenous volume load is a widely accepted prophylaxis.
In this randomized and controlled study, only patients with the need for an intra-arterial contrast media (CM) application will be included and receive a standardized, weight-based, intravenous hydration before investigation.
It is the aim of this study:
- to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN) following intra-arterial angiography in a well defined group of high-risk patients.
- to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor of contrast media induced nephropathy (CIN) after contrast media (CM) application.
- to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared to only pre-procedural volume expansion.
Patients with markedly increased urinary Neutrophil gelatinase-associated Lipocalin (NGAL) after investigation will be randomized into one of two study groups:
Patients of Group A will undergo standard treatment consisting of unrestricted oral fluid intake.
Patients of Group B will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6 hours.
Endpoints:
Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.
Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement therapy, death.
Read the detailed description
Introduction:
Over the last decades the growing demand for appropriate diagnosing and intervention in all fields of modern medicine has increased the necessity for use of iodinated contrast media (CM). Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN) and consecutively have a greater risk of death.
To date, a reliable laboratory value or test that recognizes acute renal damage before serum creatinine increases is still sought for. It would be a most helpful tool to initiate proper treatment on time. Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker predictive for acute renal injury has been shown to be capable for earlier diagnosis of contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.
So far, an intravenous volume load is the only fairly proven and widely accepted prophylaxis. However, the optimal intravenous fluid regimen regarding the type, amount, route and duration of volume application has remained controversial. Habits of giving pre- and post-procedural volume have been widely differing throughout all randomized trials and, thus, are not comparable in the available studies. Unfortunately, most studies were also lacking statistical power, used different types of contrast media (CM) and definitions of contrast media induced nephropathy (CIN) or allowed for additional prophylactic measures, such as N-acetylcysteine or sodium bicarbonate in a varying percentage of their patients.
In our randomized and controlled study, only patients with the need for an intra-arterial contrast media (CM) application will be included. Patients scheduled for a diagnostic angiography and/or endovascular intervention will receive a standardized, weight-based, intravenous hydration before investigation. Only one type of contrast media (CM) and neither sodium bicarbonate, nor N-acetylcysteine is used throughout the study. The study will be performed according to the Consort-Statement 2010 for clinical trials.
It is the aim of our study:
- to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN) following intra-arterial angiography in a well defined group of high-risk patients.
- to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor of contrast media induced nephropathy (CIN) after contrast media (CM) application.
- to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared to only pre-procedural volume expansion.
Patients with markedly increased Neutrophil gelatinase-associated Lipocalin (NGAL) values (criteria for randomization into one of two treatment groups see below) at 4 to 6 hours after investigation will be randomized into one of two study groups:
Patients of Group A will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6 hours.
Patients of Group B will undergo standard treatment consisting of unrestricted oral fluid intake, at least 500 ml tea or water provided by the ward, but no intravenous fluid application.
Criteria for Randomization (after 2nd NGAL testing):
- Patients with NGAL levels > 150 ng/ml, if baseline was below 75 ng/ml.
- Patients with doubling of NGAL values, if baseline was between 75 and 150 ng/ml.
Endpoints:
Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.
Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement therapy, death.
- Conditions
- Contrast Media Induced Nephropathy (CIN)
- Being tested
- application of intravenous volume, oral fluid application
- Keywords
- NGAL, neutrophil gelatinase-associated Lipocalin, contrast media nephropathy, CIN, volume expansion, acute kidney injury, contrast media
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of intravenous volumeOther
weight based intravenous application of volume
oral fluid applicationOther
oral fluid application
| Study group | Role | What they receive |
|---|---|---|
| intravenous hydration | Active comparator | intravenous application of 0.9% saline Receives: Other: application of intravenous volume |
| oral hydration only | Active comparator | Not described Receives: Other: oral fluid application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Contrast Media Induced Nephropathy (CIN)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diagnostics Division
- Responsible party
- Principal investigator, Gernot Schilcher, MD, Medical University of Graz
- Investigators
- Joerg Horina, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292317
- Sponsor's protocol ID
- CIN and NGAL 1.0
- Other IDs
- Ek 21-278 ex 09/10
- Status last verified
- Mar 2016
- First submitted
- 8 Feb 2011
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Reddan D, Laville M, Garovic VD. Contrast-induced nephropathy and its prevention: What do we really know from evidence-based findings? J Nephrol. 2009 May-Jun;22(3):333-51.
PubMed 19557710Haase-Fielitz A, Bellomo R, Devarajan P, Story D, Matalanis G, Dragun D, Haase M. Novel and conventional serum biomarkers predicting acute kidney injury in adult cardiac surgery--a prospective cohort study. Crit Care Med. 2009 Feb;37(2):553-60. doi: 10.1097/CCM.0b013e318195846e.
PubMed 19114878McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med. 1997 Nov;103(5):368-75. doi: 10.1016/s0002-9343(97)00150-2.
PubMed 9375704Ribitsch W, Schilcher G, Quehenberger F, Pilz S, Portugaller RH, Truschnig-Wilders M, Zweiker R, Brodmann M, Stiegler P, Rosenkranz AR, Pickering JW, Horina JH. Neutrophil gelatinase-associated lipocalin (NGAL) fails as an early predictor of contrast induced nephropathy in chronic kidney disease (ANTI-CI-AKI study). Sci Rep. 2017 Jan 27;7:41300. doi: 10.1038/srep41300.
PubMed 28128223Schilcher G, Ribitsch W, Otto R, Portugaller RH, Quehenberger F, Truschnig-Wilders M, Zweiker R, Stiegler P, Brodmann M, Weinhandl K, Horina JH. Early detection and intervention using neutrophil gelatinase-associated lipocalin (NGAL) may improve renal outcome of acute contrast media induced nephropathy: a randomized controlled trial in patients undergoing intra-arterial angiography (ANTI-CIN Study). BMC Nephrol. 2011 Aug 17;12:39. doi: 10.1186/1471-2369-12-39.
PubMed 21849080
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Intervention of Acute Contrast Media Induced Nephropathy Using Neutrophil Gelatinase-associated Lipocalin (NGAL) May Improve Renal Outcome: A Study in Patients Undergoing Intra-arterial Angiography.
- ClinicalTrials.gov ID
- NCT01292317
- Acronym / sponsor ID
- CIN and NGAL 1.0
- Conditions
- Contrast Media Induced Nephropathy (CIN)
- Keywords
- NGAL, neutrophil gelatinase-associated Lipocalin, contrast media nephropathy, CIN, volume expansion, acute kidney injury, contrast media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 819 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Abbott Diagnostics Division
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Feb 2011 (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.
Introduction:
Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker predictive for acute renal injury has been shown to be capable for earlier diagnosis of acute contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.
Intravenous volume load is a widely accepted prophylaxis.
In this randomized and controlled study, only patients with the need for an intra-arterial contrast media (CM) application will be included and receive a standardized, weight-based, intravenous hydration before investigation.
It is the aim of this study:
- to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN) following intra-arterial angiography in a well defined group of high-risk patients.
- to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor of contrast media induced nephropathy (CIN) after contrast media (CM) application.
- to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared to only pre-procedural volume expansion.
Patients with markedly increased urinary Neutrophil gelatinase-associated Lipocalin (NGAL) after investigation will be randomized into one of two study groups:
Patients of Group A will undergo standard treatment consisting of unrestricted oral fluid intake.
Patients of Group B will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6 hours.
Endpoints:
Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.
Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement therapy, death.
Detailed description
Introduction:
Over the last decades the growing demand for appropriate diagnosing and intervention in all fields of modern medicine has increased the necessity for use of iodinated contrast media (CM). Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN) and consecutively have a greater risk of death.
To date, a reliable laboratory value or test that recognizes acute renal damage before serum creatinine increases is still sought for. It would be a most helpful tool to initiate proper treatment on time. Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker predictive for acute renal injury has been shown to be capable for earlier diagnosis of contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.
So far, an intravenous volume load is the only fairly proven and widely accepted prophylaxis. However, the optimal intravenous fluid regimen regarding the type, amount, route and duration of volume application has remained controversial. Habits of giving pre- and post-procedural volume have been widely differing throughout all randomized trials and, thus, are not comparable in the available studies. Unfortunately, most studies were also lacking statistical power, used different types of contrast media (CM) and definitions of contrast media induced nephropathy (CIN) or allowed for additional prophylactic measures, such as N-acetylcysteine or sodium bicarbonate in a varying percentage of their patients.
In our randomized and controlled study, only patients with the need for an intra-arterial contrast media (CM) application will be included. Patients scheduled for a diagnostic angiography and/or endovascular intervention will receive a standardized, weight-based, intravenous hydration before investigation. Only one type of contrast media (CM) and neither sodium bicarbonate, nor N-acetylcysteine is used throughout the study. The study will be performed according to the Consort-Statement 2010 for clinical trials.
It is the aim of our study:
- to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN) following intra-arterial angiography in a well defined group of high-risk patients.
- to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor of contrast media induced nephropathy (CIN) after contrast media (CM) application.
- to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared to only pre-procedural volume expansion.
Patients with markedly increased Neutrophil gelatinase-associated Lipocalin (NGAL) values (criteria for randomization into one of two treatment groups see below) at 4 to 6 hours after investigation will be randomized into one of two study groups:
Patients of Group A will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6 hours.
Patients of Group B will undergo standard treatment consisting of unrestricted oral fluid intake, at least 500 ml tea or water provided by the ward, but no intravenous fluid application.
Criteria for Randomization (after 2nd NGAL testing):
- Patients with NGAL levels > 150 ng/ml, if baseline was below 75 ng/ml.
- Patients with doubling of NGAL values, if baseline was between 75 and 150 ng/ml.
Endpoints:
Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.
Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement therapy, death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous hydration | Active comparator | Other: application of intravenous volumeintravenous application of 0.9% saline |
| oral hydration only | Active comparator | Other: oral fluid application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with the need for intra-arterial angiography/angioplasty
- Patients older than 18 years
- Patients with clinically stable chronic renal insufficiency stage 2 and more (calculated GFR < 70 ml/min/1,73 m2)(65)
- Written informed consent
Key exclusion criteria (7 listed)
- Pre-existing clinical and/or laboratory evidence of acute renal failure at the time of enrollment
- Evidence of rhabdomyolysis
- Patients on renal replacement therapy (34)
- Patients with life-threatening underlying disease (sepsis, MOF, SIRS)
- Contraindication for volume therapy
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 |
|---|---|---|
| application of intravenous volumeweight based intravenous application of volume | Other | intravenous hydration |
| oral fluid applicationoral fluid application | Other | oral hydration only |
Primary outcome
Contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Background: PubMed 19557710Reddan D, Laville M, Garovic VD. Contrast-induced nephropathy and its prevention: What do we really know from evidence-based findings? J Nephrol. 2009 May-Jun;22(3):333-51.
- Background: PubMed 19114878Haase-Fielitz A, Bellomo R, Devarajan P, Story D, Matalanis G, Dragun D, Haase M. Novel and conventional serum biomarkers predicting acute kidney injury in adult cardiac surgery--a prospective cohort study. Crit Care Med. 2009 Feb;37(2):553-60. doi: 10.1097/CCM.0b013e318195846e.
- Background: PubMed 9375704McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med. 1997 Nov;103(5):368-75. doi: 10.1016/s0002-9343(97)00150-2.
- Derived from this study: PubMed 28128223Ribitsch W, Schilcher G, Quehenberger F, Pilz S, Portugaller RH, Truschnig-Wilders M, Zweiker R, Brodmann M, Stiegler P, Rosenkranz AR, Pickering JW, Horina JH. Neutrophil gelatinase-associated lipocalin (NGAL) fails as an early predictor of contrast induced nephropathy in chronic kidney disease (ANTI-CI-AKI study). Sci Rep. 2017 Jan 27;7:41300. doi: 10.1038/srep41300.
- Derived from this study: PubMed 21849080Schilcher G, Ribitsch W, Otto R, Portugaller RH, Quehenberger F, Truschnig-Wilders M, Zweiker R, Stiegler P, Brodmann M, Weinhandl K, Horina JH. Early detection and intervention using neutrophil gelatinase-associated lipocalin (NGAL) may improve renal outcome of acute contrast media induced nephropathy: a randomized controlled trial in patients undergoing intra-arterial angiography (ANTI-CIN Study). BMC Nephrol. 2011 Aug 17;12:39. doi: 10.1186/1471-2369-12-39.
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Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
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Not yet recruitingEarly Phase 1
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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.
Joerg Horina, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of intravenous volume and oral fluid application in people with Contrast Media Induced Nephropathy (CIN), run by Medical University of Graz at 1 site in Austria.
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 7 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: finished, as of the sponsor's last update on 18 Mar 2016. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine. (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292317, which also lists 5 linked publications.
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 18 Mar 2016.