Sodium Bicarbonate and N-Acetylcysteine for Nephroprotection in Acute Myocardial Infarction

NCT01218178 | Completed

• 1 other identifier: P/479/CE/2010
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology, especially in the acute setting of primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute myocardial infarction.

Conditions

Acute Myocardial Infarction; Acute Kidney Injury

Keywords

acute myocardial infarction; acute kidney injury; contrast induced nephropathy; primary PCI; sodium-bicarbonate; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• All cause mortality, contrast-induced nephropathy and need of dialysis.

  To test the efficacy of sodium bicarbonate plus N-acetylcysteine vs saline hydration plus N-acetylcysteine to reduce mortality and to prevent contrast-induced nephropathy in the setting of primary PCI.

  2010

Study Arms (2)

Sodium bicarbonate plus NAC

Sodium bicarbonate plus NAC

Drug: Sodium bicarbonate plus NAC

Saline hydration plus NAC

Saline hydration plus NAC

Drug: Saline hydration plus NAC

Interventions

Sodium bicarbonate plus NAC DRUG

154 mEq/L sodium bicarbonate (infusion rate of 3 ml/Kg for 1 hour followed by 1 ml/Kg for 6 hours) plus NAC (1200 mg bid for 48 hours)

Sodium bicarbonate plus NAC

Saline hydration plus NAC DRUG

0.9% saline (1 ml/Kg for 12 hours) plus NAC (1200 mg bid for 48 hours)

Saline hydration plus NAC

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

• Consecutive patients admitted from ER of the Policlinico Agostino Gemelli and Casilino of Rome with a ST-Segment Elevation Myocardial Infarction undergoing urgent PCI

You may qualify if:

• ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:
• ischemic symptoms;
• ECG variations: ST-elevation (\>0,05 mV) in two or more contiguous leads;
• Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT). • Indication to urgent coronary angiography and primary or rescue PCI

You may not qualify if:

• Patients with history of allergic reaction to NAC
• Chronic hemodialysis
• Age \>= 90 years

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Policlinico Casilino ASL RMB: collaborator

Study Sites (1)

Policlinico Agostino Gemelli and Policlinico Casilino

Rome, 00168, Italy

Location

Related Publications (17)

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  PMID: 10075613 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

• Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.

  PMID: 15464318 BACKGROUND

• Wright RS, Reeder GS, Herzog CA, Albright RC, Williams BA, Dvorak DL, Miller WL, Murphy JG, Kopecky SL, Jaffe AS. Acute myocardial infarction and renal dysfunction: a high-risk combination. Ann Intern Med. 2002 Oct 1;137(7):563-70. doi: 10.7326/0003-4819-137-7-200210010-00007.

  PMID: 12353943 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

• Adolph E, Holdt-Lehmann B, Chatterjee T, Paschka S, Prott A, Schneider H, Koerber T, Ince H, Steiner M, Schuff-Werner P, Nienaber CA. Renal Insufficiency Following Radiocontrast Exposure Trial (REINFORCE): a randomized comparison of sodium bicarbonate versus sodium chloride hydration for the prevention of contrast-induced nephropathy. Coron Artery Dis. 2008 Sep;19(6):413-9. doi: 10.1097/MCA.0b013e3283021ac6.

  PMID: 18955835 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

• Tepel M, van der Giet M, Schwarzfeld C, Laufer U, Liermann D, Zidek W. Prevention of radiographic-contrast-agent-induced reductions in renal function by acetylcysteine. N Engl J Med. 2000 Jul 20;343(3):180-4. doi: 10.1056/NEJM200007203430304.

  PMID: 10900277 BACKGROUND

• Chandel NS, McClintock DS, Feliciano CE, Wood TM, Melendez JA, Rodriguez AM, Schumacker PT. Reactive oxygen species generated at mitochondrial complex III stabilize hypoxia-inducible factor-1alpha during hypoxia: a mechanism of O2 sensing. J Biol Chem. 2000 Aug 18;275(33):25130-8. doi: 10.1074/jbc.M001914200.

  PMID: 10833514 BACKGROUND

• DiMari J, Megyesi J, Udvarhelyi N, Price P, Davis R, Safirstein R. N-acetyl cysteine ameliorates ischemic renal failure. Am J Physiol. 1997 Mar;272(3 Pt 2):F292-8. doi: 10.1152/ajprenal.1997.272.3.F292.

  PMID: 9087670 BACKGROUND

• Briguori C, Airoldi F, D'Andrea D, Bonizzoni E, Morici N, Focaccio A, Michev I, Montorfano M, Carlino M, Cosgrave J, Ricciardelli B, Colombo A. Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation. 2007 Mar 13;115(10):1211-7. doi: 10.1161/CIRCULATIONAHA.106.687152. Epub 2007 Feb 19.

  PMID: 17309916 BACKGROUND

• Solomon R, Deray G; Consensus Panel for CIN. How to prevent contrast-induced nephropathy and manage risk patients: practical recommendations. Kidney Int Suppl. 2006 Apr;(100):S51-3. doi: 10.1038/sj.ki.5000375. No abstract available.

  PMID: 16612402 BACKGROUND

• McCullough 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.

  PMID: 9375704 BACKGROUND

• Navaneethan SD, Singh S, Appasamy S, Wing RE, Sehgal AR. Sodium bicarbonate therapy for prevention of contrast-induced nephropathy: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Apr;53(4):617-27. doi: 10.1053/j.ajkd.2008.08.033. Epub 2008 Nov 22.

  PMID: 19027212 BACKGROUND

• Solomon R. The role of osmolality in the incidence of contrast-induced nephropathy: a systematic review of angiographic contrast media in high risk patients. Kidney Int. 2005 Nov;68(5):2256-63. doi: 10.1111/j.1523-1755.2005.00684.x.

  PMID: 16221227 BACKGROUND

• Ozcan EE, Guneri S, Akdeniz B, Akyildiz IZ, Senaslan O, Baris N, Aslan O, Badak O. Sodium bicarbonate, N-acetylcysteine, and saline for prevention of radiocontrast-induced nephropathy. A comparison of 3 regimens for protecting contrast-induced nephropathy in patients undergoing coronary procedures. A single-center prospective controlled trial. Am Heart J. 2007 Sep;154(3):539-44. doi: 10.1016/j.ahj.2007.05.012.

  PMID: 17719303 BACKGROUND

• Leone AM, De Caterina AR, Sciahbasi A, Aurelio A, Basile E, Porto I, Trani C, Burzotta F, Niccoli G, Mongiardo R, Mazzari MA, Buffon A, Panocchia N, Romagnoli E, Lioy E, Rebuzzi AG, Crea F. Sodium bicarbonate plus N-acetylcysteine to prevent contrast-induced nephropathy in primary and rescue percutaneous coronary interventions: the BINARIO (BIcarbonato e N-Acetil-cisteina nell'infaRto mIocardico acutO) study. EuroIntervention. 2012 Nov 22;8(7):839-47. doi: 10.4244/EIJV8I7A127.

  PMID: 23171803 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Antonio Maria Leone, MD, PhD

  Catholic University of the Sacred Heart, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 11, 2010
• Study Start: June 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 13, 2015

Record last verified: 2015-03

Locations

IT (1)