Contrast Induced NephropathyNCT01160627
Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
A study testing Hydration, Acetylcysteine and Sodium bicarbonate in people with Contrast Induced Nephropathy, run by Odense University Hospital at 1 site in Denmark.
Trial summary
OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention. DESIGN: Prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Nephropathy
- What is being tested?
- Hydration, Acetylcysteine and Sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Mar 2013
- 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
- STEMI patients treated with primary PCI
Who cannot join
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.
DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine >25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.
Read more
Patients will be randomised to:
- Standard treatment
- Standard treatment + acetylcystein for 2 days
- Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
- Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
- Conditions
- Contrast Induced Nephropathy
- Being tested
- Hydration, Acetylcysteine, Sodium bicarbonate, Combined Acetylcystein and Sodium Bicarbonate
- Keywords
- CIN STEMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrationOther
Saline hydration
AcetylcysteineDrug
Acetylcystein tablets for 2 days
Sodium bicarbonateDrug
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
Combined Acetylcystein and Sodium BicarbonateDrug
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Hydration Receives: Other: Hydration |
| Combined Acetylcystein and Sodium Bicarbonat | Active comparator | Not described Receives: Drug: Combined Acetylcystein and Sodium Bicarbonate |
| Sodium Bicarbonate | Active comparator | Not described Receives: Drug: Sodium bicarbonate |
| Acetylcystein for 2 days | Active comparator | Standard treatment + acetylcystein for 2 days Receives: Drug: Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Rise in creatinine >25% from baseline to day 3
Measured: from baseline to day 3
Secondary outcomes (1)
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Rise in creatinine >25% from baseline to day 30
Measured: from baseline to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Induced NephropathyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisette Okkels Jensen, Odense University Hospital
- Investigators
- Per Thayssen, MD DMSci, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160627
- Sponsor's protocol ID
- CIN in STEMI
- Status last verified
- Mar 2013
- First submitted
- 9 Jul 2010
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.
PubMed 24714489
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01160627
- Acronym / sponsor ID
- CIN in STEMI
- Conditions
- Contrast Induced Nephropathy
- Keywords
- CIN STEMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Jul 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.
OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.
DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine >25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.
Patients will be randomised to:
- Standard treatment
- Standard treatment + acetylcystein for 2 days
- Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
- Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Other: HydrationHydration |
| Combined Acetylcystein and Sodium Bicarbonat | Active comparator | Drug: Combined Acetylcystein and Sodium Bicarbonate |
| Sodium Bicarbonate | Active comparator | Drug: Sodium bicarbonate |
| Acetylcystein for 2 days | Active comparator | Drug: AcetylcysteineStandard treatment + acetylcystein for 2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- STEMI patients treated with primary PCI
Key exclusion criteria (1 listed)
- Cardiogenic shock
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 |
|---|---|---|
| HydrationSaline hydration | Other | Standard treatment |
| AcetylcysteineAcetylcystein tablets for 2 days | Drug | Acetylcystein for 2 days |
| Sodium bicarbonateSodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours | Drug | Sodium Bicarbonate |
| Combined Acetylcystein and Sodium BicarbonateSodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days | Drug | Combined Acetylcystein and Sodium Bicarbonat |
Primary outcome
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Time frame: from baseline to day 3
Rise in creatinine >25% from baseline to day 3
1 secondary outcome
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Time frame: from baseline to day 30
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 22 Mar 2013.
- Derived from this study: PubMed 24714489Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.
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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.
Per Thayssen, MD DMSci principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration, Acetylcysteine and Sodium bicarbonate in people with Contrast Induced Nephropathy, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 22 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 Denmark. 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?
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI (time frame: from baseline to day 3). 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 NCT01160627, which also lists 1 linked publication.
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 22 Mar 2013.