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

NCT00639912 | Completed Phase 4

• 1 other identifier: MAN1374
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Contrast Induced Nephropathy

Keywords

contrast induced nephropathy STEMI PCI

Outcome Measures

Primary Outcomes (1)

• contrast induced nephropathy incidence

  24, 48 and 72 hours

Study Arms (4)

A: low volume saline

ACTIVE COMPARATOR

Solution 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.

Drug: sodium chloride

B: high volume saline

ACTIVE COMPARATOR

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 after the procedure, starting in the Cath lab.

Drug: sodium chloride

C: low volume sodium bicarbonate

ACTIVE COMPARATOR

Solution 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.

Drug: sodium bicarbonate

D: high volume sodium bicarbonate

ACTIVE COMPARATOR

Solution 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.

Drug: sodium bicarbonate

Interventions

sodium chloride DRUG

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

Also known as: Normal saline. Isotonic saline. Sodium chloride 0.9% .

A: low volume saline

sodium bicarbonate DRUG

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

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

C: low volume sodium bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Azienda Sanitaria Ospedaliera: collaborator

Study Sites (5)

Azienda Ospedaliera Universitaria S. Anna

Ferrara, Emilia-Romagna, Italy

Location

Nuovo Ospedale Civile di Baggiovara

Modena, Emilia-Romagna, 41100, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Dipartimento di Cardiologia, Ospedale di Lavagna

Lavagna, Genova, 16033, Italy

Location

Dipartimento di Cardiologia, Ospedale Maggiore

Parma, Parma, 43100, Italy

Location

Related Publications (5)

• 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.

  PMID: 16949378 BACKGROUND

• 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.

  PMID: 15519007 BACKGROUND

• 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.

  PMID: 16807414 BACKGROUND

• 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.

  PMID: 15150204 BACKGROUND

• 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.

  PMID: 24500238 DERIVED

MeSH Terms

Interventions

Sodium Chloride; Sodium Bicarbonate; Glucose

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Antonio Manari, MD

  Arcispedale S. Maria Nuova Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: June 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 11, 2025

Record last verified: 2008-03

Locations

IT (5)