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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic | Active Comparator | Use of Hypertonic solution during left marginal branch CABG surgery. |
|
| Isotonic | Placebo Comparator | Use of Isotonic solution during left marginal branch CABG surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic solution | Drug | Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto R Silva, MD PHD | Contact | 55-11-45215757 | rochaesilva@incor.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| ROBERTO R Silva, MD PHD | Hospital Pitangueiras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pitangueiras | Recruiting | Jundiaà | São Paulo | 1295 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6776826 | Background | 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. doi: 10.1152/ajpheart.1980.239.5.H664. | |
| 7689115 | Background | Rocha e Silva M, Braga GA, Prist R, Velasco IT, Granca ES. Isochloremic hypertonic solutions for severe hemorrhage. J Trauma. 1993 Aug;35(2):200-5. doi: 10.1097/00005373-199308000-00005. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| ID | Term |
|---|---|
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Isotonic | Drug | Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery. |
|
| 9308620 | Background | 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. doi: 10.1016/s0039-6060(97)90135-5. |
| 1697790 | Background | Mazzoni MC, Borgstrom 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. |
| 1423912 | Background | Ramires JA, Serrano Junior CV, Cesar LA, Velasco IT, Rocha e Silva Junior 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. |
| 3576451 | Background | 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. |
| 11269449 | Background | 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. doi: 10.1016/s0003-4975(00)02393-6. |
| 2012420 | Background | 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. doi: 10.1016/0003-4975(91)90320-p. |
| 1721516 | Background | 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. doi: 10.1093/bja/67.5.595. |
|
| 7544684 | Background | 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. |
| 10548199 | Background | Sirieix D, Hongnat JM, Delayance S, D'Attellis N, Vicaut E, Berrebi 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. doi: 10.1097/00003246-199910000-00014. |
| 9509195 | Background | Tollofsrud 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. doi: 10.1111/j.1399-6576.1998.tb05101.x. |
| 14560106 | Background | Rocha-E-Silva R, Caneo LF, Lourenco 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. doi: 10.1097/01.SHK.0000094037.09886.d2. |
| 19878097 | Background | 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. |
| 12392272 | Background | 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. doi: 10.1097/00024382-200210000-00003. |
| 15561035 | Background | 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. doi: 10.1016/j.athoracsur.2004.05.059. |
| 18583284 | Background | 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. |
| 12486647 | Background | 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. doi: 10.1053/jcan.2002.128418. |
| 3719918 | Background | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |