Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

Coronary Artery Disease Clinical Trial

Official title:

Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01463917
• Other study ID #: hypertonic off pump CABS
• Status: Recruiting
• Phase: Phase 4
• First received: October 19, 2011
• Last updated: October 31, 2011
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2011
• Source: Hospital Pitangueiras
• Contact: Roberto R Silva, MD PHD
• Phone: 55-11-45215757
• Email: rochaesilva[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a comparison between Hypertonic versus isotonic solution in a double blind randomized trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal branch.

Hypertonic solution should provide better tolerance for heart mobilization with less volume expansion and less drugs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Off pump CABG targeting the left marginal branch

Exclusion Criteria:

• On pump surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Hypertonic solution
Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.
• Isotonic
Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.

Locations

Country	Name	City	State
Brazil	Hospital Pitangueiras	Jundiai	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Pitangueiras

Country where clinical trial is conducted

Brazil, 

References & Publications (19)

Auler JO Jr, Pereira MH, Gomide-Amaral RV, Stolf NG, Jatene AD, Rocha e Silva M. Hemodynamic effects of hypertonic sodium chloride during surgical treatment of aortic aneurysms. Surgery. 1987 May;101(5):594-601. — View Citation

Boldt J, Zickmann B, Ballesteros M, Herold C, Dapper F, Hempelmann G. Cardiorespiratory responses to hypertonic saline solution in cardiac operations. Ann Thorac Surg. 1991 Apr;51(4):610-5. — View Citation

Boldt J, Zickmann B, Herold C, Ballesteros M, Dapper F, Hempelmann G. Influence of hypertonic volume replacement on the microcirculation in cardiac surgery. Br J Anaesth. 1991 Nov;67(5):595-602. — View Citation

Chang WI, Kim KB, Kim JH, Ham BM, Kim YL. Hemodynamic changes during posterior vessel off-pump coronary artery bypass: comparison between deep pericardial sutures and vacuum-assisted apical suction device. Ann Thorac Surg. 2004 Dec;78(6):2057-62. — View Citation

DeFoe GR, Ross CS, Olmstead EM, Surgenor SD, Fillinger MP, Groom RC, Forest RJ, Pieroni JW, Warren CS, Bogosian ME, Krumholz CF, Clark C, Clough RA, Weldner PW, Lahey SJ, Leavitt BJ, Marrin CA, Charlesworth DC, Marshall P, O'Connor GT. Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting. Northern New England Cardiovascular Disease Study Group. Ann Thorac Surg. 2001 Mar;71(3):769-76. — View Citation

Kvalheim VL, Farstad M, Steien E, Mongstad A, Borge BA, Kvitting PM, Husby P. Infusion of hypertonic saline/starch during cardiopulmonary bypass reduces fluid overload and may impact cardiac function. Acta Anaesthesiol Scand. 2010 Apr;54(4):485-93. doi: 10.1111/j.1399-6576.2009.02156.x. Epub 2009 Oct 29. — View Citation

Mazzoni MC, Borgström P, Intaglietta M, Arfors KE. Capillary narrowing in hemorrhagic shock is rectified by hyperosmotic saline-dextran reinfusion. Circ Shock. 1990 Aug;31(4):407-18. — View Citation

Mishra M, Malhotra R, Mishra A, Meharwal ZS, Trehan N. Hemodynamic changes during displacement of the beating heart using epicardial stabilization for off-pump coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2002 Dec;16(6):685-90. — View Citation

Mustafa I, Leverve XM. Metabolic and hemodynamic effects of hypertonic solutions: sodium-lactate versus sodium chloride infusion in postoperative patients. Shock. 2002 Oct;18(4):306-10. — View Citation

Oliveira SA, Bueno RM, Souza JM, Senra DF, Rocha-e-Silva M. Effects of hypertonic saline dextran on the postoperative evolution of Jehovah's Witness patients submitted to cardiac surgery with cardiopulmonary bypass. Shock. 1995 Jun;3(6):391-4. — View Citation

Ozay B, Sargin M, Abay G, Ketenci B, Kut S, Enc Y, Orhan G, Teskin O, Demirtas M. The severity of positional mitral regurgitation during off-pump coronary artery bypass grafting. Heart Surg Forum. 2008;11(3):E145-51. doi: 10.1532/HSF98.20071191. — View Citation

Ramires JA, Serrano Júnior CV, César LA, Velasco IT, Rocha e Silva Júnior M, Pileggi F. Acute hemodynamic effects of hypertonic (7.5%) saline infusion in patients with cardiogenic shock due to right ventricular infarction. Circ Shock. 1992 Jul;37(3):220-5. — View Citation

Rocha e Silva M, Braga GA, Prist R, Velasco IT, Grança ES. Isochloremic hypertonic solutions for severe hemorrhage. J Trauma. 1993 Aug;35(2):200-5. — View Citation

Rocha-e-Silva M, Negraes GA, Soares AM, Pontieri V, Loppnow L. Hypertonic resuscitation from severe hemorrhagic shock: patterns of regional circulation. Circ Shock. 1986;19(2):165-75. — View Citation

Rocha-E-Silva R, Canêo LF, Lourenço Filho DD, Jatene MB, Barbero-Marcial M, Oliveira SA, Rocha-E-Silva M. First use of hypertonic saline dextran in children: a study in safety and effectiveness for atrial septal defect surgery. Shock. 2003 Nov;20(5):427-30. — View Citation

Sirieix D, Hongnat JM, Delayance S, D'Attellis N, Vicaut E, Bérrébi A, Paris M, Fabiani JN, Carpentier A, Baron JF. Comparison of the acute hemodynamic effects of hypertonic or colloid infusions immediately after mitral valve repair. Crit Care Med. 1999 Oct;27(10):2159-65. — View Citation

Tølløfsrud S, Noddeland H. Hypertonic saline and dextran after coronary artery surgery mobilises fluid excess and improves cardiorespiratory functions. Acta Anaesthesiol Scand. 1998 Feb;42(2):154-61. — View Citation

Velasco IT, Pontieri V, Rocha e Silva M Jr, Lopes OU. Hyperosmotic NaCl and severe hemorrhagic shock. Am J Physiol. 1980 Nov;239(5):H664-73. — View Citation

Wade CE, Kramer GC, Grady JJ, Fabian TC, Younes RN. Efficacy of hypertonic 7.5% saline and 6% dextran-70 in treating trauma: a meta-analysis of controlled clinical studies. Surgery. 1997 Sep;122(3):609-16. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of vasoactive drugs in left marginal branch off pump CABG surgery	Comparison between hypertonic and isotonic solutions for need of vasoactive drugs with heart mobilization during left marginal branch off pump CABG surgery. Data will be collected respectively at 1, 5 and 10 minutes after beggining the left branch coronary anastomosis. Data will be type of drug need and dosage until the end os the anastomosis.	time related to left branch coronary anastomosis for drug need.	No
Secondary	Fluid balance	Comparison of fluid balance in the operative period between hypertonic and isotonic solutions. Data will be collected at the end of surgery and by next mornning.	Operative period and first operative day	No