Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery
Sponsor
Hospital Pitangueiras (Other)
Overall Status
Unknown status
CT.gov ID
NCT01463917
Collaborator
(none)
20
1
2
7
2.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch
Study Start Date
:
Sep 1, 2011
Anticipated Primary Completion Date
:
Mar 1, 2012
Anticipated Study Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Hypertonic Use of Hypertonic solution during left marginal branch CABG surgery. |
Drug: Hypertonic solution
Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.
|
| Placebo Comparator: Isotonic Use of Isotonic solution during left marginal branch CABG surgery. |
Drug: Isotonic
Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.
|
Outcome Measures
Primary Outcome Measures
- Use of vasoactive drugs in left marginal branch off pump CABG surgery [time related to left branch coronary anastomosis for drug need.]
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.
Secondary Outcome Measures
- Fluid balance [Operative period and first operative day]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Off pump CABG targeting the left marginal branch
Exclusion Criteria:
- On pump surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Pitangueiras | Jundiai | Sao Paulo | Brazil | 1295 |
Sponsors and Collaborators
- Hospital Pitangueiras
Investigators
- Principal Investigator: ROBERTO R Silva, MD PHD, Hospital Pitangueiras
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Retraction in: Br J Anaesth. 2020 Sep;125(3):412-413.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Roberto Rocha e Silva,
Chief, Adult Heart Surgery, MD PHD in Cardiovascular Surgery,
Hospital Pitangueiras
ClinicalTrials.gov Identifier:
NCT01463917
Other Study ID Numbers:
- hypertonic off pump CABS
First Posted:
Nov 2, 2011
Last Update Posted:
Nov 2, 2011
Last Verified:
Oct 1, 2011
Keywords provided by Roberto Rocha e Silva,
Chief, Adult Heart Surgery, MD PHD in Cardiovascular Surgery,
Hospital Pitangueiras
Additional relevant MeSH terms: