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Contrast Induced NephropathyPhase 4CINIMANCT00639912

Effects of Hydration to Prevent Contrast Induced Nephropathy in PCI for ST-elevation Myocardial Infarction.

A Phase 4 study testing sodium chloride and sodium bicarbonate in people with Contrast Induced Nephropathy, run by Azienda USL Reggio Emilia - IRCCS at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI. 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?
sodium chloride and sodium bicarbonate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
599 participants
Where
5 sitesItaly
Study dates
Jun 2007to Oct 2010
Phase
Phase 4
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

  • Age > 18 years of years
  • Chest pain lasting at least 30 minutes, non responsive to nitrates, associated to ST elevation of at least 0.2 mV on surface ECG in two or more contiguous leads or to new left bundle branch block.
  • Informed consent

Who cannot join

  • Chronic hemodialytic or peritoneal treatment
  • Coronary anatomy unsuitable for PCI
  • Need of emergency coronary artery by-pass grafting
  • Post-anoxic coma
  • Pregnancy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • Azienda Ospedaliera Universitaria S. Anna

    Ferrara, Emilia-Romagna

  • Dipartimento di Cardiologia, Ospedale di Lavagna

    Lavagna, Genova, 16033

  • Nuovo Ospedale Civile di Baggiovara

    Modena, Emilia-Romagna, 41100

  • Dipartimento di Cardiologia, Ospedale Maggiore

    Parma, Parma, 43100

  • Arcispedale S. Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100

Other trials in Italy

About this study

Official title: Randomized Trial on the Effects of Hydration With Sodium Chloride Versus Sodium Bicarbonate to Prevent Contrast Induced Nephropathy, in Patients Undergoing Primary Coronary Interventions for Acute ST Elevation Myocardial Infarction.

The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.

Read the detailed description

Contrast-induced nephropathy (CIN) is associated with increased morbidity and mortality after percutaneous coronary interventions (PCI). Patients with ST elevation myocardial infarction (STEMI) are at high risk for CIN because of hemodynamic instability of the patient, inability to prevent the phenomenon (hydration) and the possible exposure to high volume of contrast media. Recent reports have shown incidence of CIN up to 19% in this population and a related increase of in-hospital mortality.

Merten e coll. (JAMA 2004) reported that sodium bicarbonate infusion before and after contrast exposure in patients with chronic renal failure and without myocardial infarction (AMI) is more effective than sodium chloride in preventing CIN.

Up to date there is no evidence of any effective prophylactic measures in patients with STEMI undergoing primary PCI.

The aim of the study is to test the efficacy of low versus high volume hydration and the efficacy of two different solutions (sodium chloride versus sodium bicarbonate) in preventing CIN in STEMI patients undergoing primary PCI.

The infusion of the randomized solution will start just after randomization and after determination of baseline serum creatinine.

Determination of serum creatinine will be repeated at 24, 48 and 72 hours after randomization. Creatinine clearance will be calculated with Cockroft-Gault formula and MDRD.

Being tested
sodium chloride, sodium bicarbonate
Keywords
contrast induced nephropathy STEMI PCI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sodium chlorideDrug

    Also called Normal saline. Isotonic saline. Sodium chloride 0.9% .

    Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.

  • sodium chlorideDrug

    Also called Normal saline. Isotonic saline. Sodium Chloride 0.9% .

    Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours

  • sodium bicarbonateDrug

    Also called Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.

    154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.

  • sodium bicarbonateDrug

    Also called Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.

    154 mEq/L of sodium chloride in dextrose solution. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours.

Study groups in NCT00639912
Study groupRoleWhat they receive
A: low volume salineActive comparatorSolution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/kg/hour for 12 hours after the procedure, starting in the Cath Lab.
Receives: Drug: sodium chloride
B: high volume salineActive comparatorSolution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath lab.
Receives: Drug: sodium chloride
C: low volume sodium bicarbonateActive comparatorSolution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.
Receives: Drug: sodium bicarbonate
D: high volume sodium bicarbonateActive comparatorSolution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.
Receives: Drug: sodium bicarbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. contrast induced nephropathy incidence

    Measured: 24, 48 and 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionMay 2010
  4. Study completionOct 2010

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00639912
Sponsor's protocol ID
MAN1374
Acronym
CINIMA
Status last verified
Mar 2008
First submitted
14 Mar 2008
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No

Publications

  • McCullough PA, Adam A, Becker CR, Davidson C, Lameire N, Stacul F, Tumlin J; CIN Consensus Working Panel. Risk prediction of contrast-induced nephropathy. Am J Cardiol. 2006 Sep 18;98(6A):27K-36K. doi: 10.1016/j.amjcard.2006.01.022. Epub 2006 Feb 23.

    PubMed 16949378

  • Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.

    PubMed 15519007

  • Marenzi G, Assanelli E, Marana I, Lauri G, Campodonico J, Grazi M, De Metrio M, Galli S, Fabbiocchi F, Montorsi P, Veglia F, Bartorelli AL. N-acetylcysteine and contrast-induced nephropathy in primary angioplasty. N Engl J Med. 2006 Jun 29;354(26):2773-82. doi: 10.1056/NEJMoa054209.

    PubMed 16807414

  • Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.

    PubMed 15150204

  • Manari A, Magnavacchi P, Puggioni E, Vignali L, Fiaccadori E, Menozzi M, Tondi S, Robotti S, Ferrari D, Valgimigli M. Acute kidney injury after primary angioplasty: effect of different hydration treatments. J Cardiovasc Med (Hagerstown). 2014 Jan;15(1):60-7. doi: 10.2459/JCM.0b013e3283641bb8.

    PubMed 24500238

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sodium chloride and sodium bicarbonate in people with Contrast Induced Nephropathy, run by Azienda USL Reggio Emilia - IRCCS at 5 sites in Italy.

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 3 inclusion and 5 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 induced nephropathy incidence (time frame: 24, 48 and 72 hours). 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 NCT00639912, 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 11 Jun 2025.

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