Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia

NCT02303704 | Completed Phase 2 Results

• 1 other identifier: multanic
• Study Type: interventional
• Target: 448
• Locations: 0 countries
• Sites: N/A

Brief Summary

In spite improvements in methods of myocardial protection, peri-operative myocardial damage is still the commonest cause of early morbidity and mortality after technically successful CABG Surgery. What is the optimum method of myocardial protection is still debatable. The investigators conducted this study to see effects of multiport antegrade cold blood cardioplegia on myocardial protection, along with continuous controlled warm blood perfusion through veins graft during proximal ends anastomosis in conventional CABG surgery in patients having multi-vessel disease.

Conditions

Coronary Artery Bypass Surgery

Keywords

Multiperfusion set; Myocardial protection; Coronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

• Post-op CK-MB Levels

  CK-MB is a marker of Myocardial Damage.

  36 hours after surgery.

Secondary Outcomes (5)

• Pharmacologic Inotropic Support (Adrenaline)

  Upto 1 week after sugery

• Pharmacological Inotropic Support (Nor-adrenaline)

  Upto 1 week after sugery

• Pharamacological Inotropic Support (Dobutamine)

  Upto 1 week after sugery

• Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support

  24 hours before surgery and upto 1 week of surgical procedure.

• Operative Mortality

  Within 30 days after surgical Procedure

Study Arms (2)

multiport antegrade cardioplegia

ACTIVE COMPARATOR

Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.

Procedure: multiport antegrade cardioplegia

Aortic root antegrade cardioplegia

ACTIVE COMPARATOR

Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion

Procedure: Aortic root antegrade cardioplegia

Interventions

multiport antegrade cardioplegia PROCEDURE

Cold blood cardioplegia was used for myocardial protection and just before the removal of the aortic cross-clamp, warm blood shot (normo-kalemic) was started through multi-perfusion set attached to cardioplegia cannula in the aortic root and vein grafts.As contraction of heart started the multiport limb attached to cardioplegia cannula was off and cross clamp was removed .The warm perfusion through the vein grafts was continued at controlled pressures of about 50-70 mmHg, flow rate of 10-30ml/min/graft and temperature of 35-37 oC

Also known as: multiperfusion set

multiport antegrade cardioplegia

Aortic root antegrade cardioplegia PROCEDURE

only cold blood cardioplegia was used for myocardial protection without hotshot.

Aortic root antegrade cardioplegia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing isolated conventional CABG were included in the study

You may not qualify if:

• The redo CABG surgery. Those who required 2 or less than 2 grafts. Patients who had major postoperative neurological complications like stroke. 2nd arterial graft along with LIMA. Patients who need CABG within a week of STEMI or NSTEMI. Patients with calcified or diseased aorta in which single cross clamp technique was used for proximal aorto-coronary anastomosis

Sponsors & Collaborators

• Chaudhry Pervaiz Elahi Institute of Cardiology: lead

Related Publications (22)

• Mack MJ, Brown PP, Kugelmass AD, Battaglia SL, Tarkington LG, Simon AW, Culler SD, Becker ER. Current status and outcomes of coronary revascularization 1999 to 2002: 148,396 surgical and percutaneous procedures. Ann Thorac Surg. 2004 Mar;77(3):761-6; discussion 766-8. doi: 10.1016/j.athoracsur.2003.06.019.

  PMID: 14992867 BACKGROUND

• Onorati F, De Feo M, Mastroroberto P, Cristodoro L, Pezzo F, Renzulli A, Cotrufo M. Determinants and prognosis of myocardial damage after coronary artery bypass grafting. Ann Thorac Surg. 2005 Mar;79(3):837-45. doi: 10.1016/j.athoracsur.2004.07.060.

  PMID: 15734390 BACKGROUND

• Steuer J, Horte LG, Lindahl B, Stahle E. Impact of perioperative myocardial injury on early and long-term outcome after coronary artery bypass grafting. Eur Heart J. 2002 Aug;23(15):1219-27. doi: 10.1053/euhj.2002.3171.

  PMID: 12127924 BACKGROUND

• Soltesz EG, Laurence RG, De Grand AM, Cohn LH, Mihaljevic T, Frangioni JV. Image-guided quantification of cardioplegia delivery during cardiac surgery. Heart Surg Forum. 2007;10(5):E381-6. doi: 10.1532/HSF98.20071099.

  PMID: 17855203 BACKGROUND

• Sanjay OP, Srikrishna SV, Prashanth P, Kajrekar P, Vincent V. Antegrade versus antegrade with retrograde delivery of cardioplegic solution in myocardial revascularisation. A clinical study in patients with triple vessel coronary artery disease. Ann Card Anaesth. 2003 Jul;6(2):143-8.

  PMID: 17827576 BACKGROUND

• Teoh KH, Christakis GT, Weisel RD, Fremes SE, Mickle DA, Romaschin AD, Harding RS, Ivanov J, Madonik MM, Ross IM, et al. Accelerated myocardial metabolic recovery with terminal warm blood cardioplegia. J Thorac Cardiovasc Surg. 1986 Jun;91(6):888-95.

  PMID: 3520161 BACKGROUND

• Onorati F, Renzulli A, De Feo M, Santarpino G, Gregorio R, Biondi A, Cerasuolo F, Cotrufo M. Does antegrade blood cardioplegia alone provide adequate myocardial protection in patients with left main stem disease? J Thorac Cardiovasc Surg. 2003 Nov;126(5):1345-51. doi: 10.1016/s0022-5223(03)00736-0.

  PMID: 14666005 BACKGROUND

• Tian G, Xiang B, Dai G, Sun J, Lindsay WG, Deslauriers R. Simultaneous antegrade/retrograde cardioplegia protects myocardium distal to a coronary occlusion: a study in isolated pig hearts. Magn Reson Med. 2001 Oct;46(4):773-80. doi: 10.1002/mrm.1256.

  PMID: 11590654 BACKGROUND

• Allen BS, Winkelmann JW, Hanafy H, Hartz RS, Bolling KS, Ham J, Feinstein S. Retrograde cardioplegia does not adequately perfuse the right ventricle. J Thorac Cardiovasc Surg. 1995 Jun;109(6):1116-24; discussion 1124-6. doi: 10.1016/S0022-5223(95)70195-8.

  PMID: 7776676 BACKGROUND

• Ardehali A, Gates RN, Laks H, Drinkwater DC Jr, Rudis E, Sorensen TJ, Chang P, Aharon A. The regional capillary distribution of retrograde blood cardioplegia in explanted human hearts. J Thorac Cardiovasc Surg. 1995 May;109(5):935-9; discussion 939-40. doi: 10.1016/S0022-5223(95)70319-5.

  PMID: 7739255 BACKGROUND

• Carrier M, Gregoire J, Khalil A, Thai P, Latour JG, Pelletier LC. Myocardial distribution of retrograde cardioplegic solution assessed by myocardial thallium 201 uptake. J Thorac Cardiovasc Surg. 1994 Dec;108(6):1115-8.

  PMID: 7983880 BACKGROUND

• Sabzi F, Zokaei A. Factors predicting coronary sinus rupture following cannula insertion for retrograde cardioplegia. Clin Med Insights Cardiol. 2012;6:1-6. doi: 10.4137/CMC.S7861. Epub 2011 Dec 6.

  PMID: 22259260 BACKGROUND

• Panos AL, Ali IS, Birnbaum PL, Barrozo CA, al-Nowaiser O, Salerno TA. Coronary sinus injuries during retrograde continuous normothermic blood cardioplegia. Ann Thorac Surg. 1992 Dec;54(6):1137-8. doi: 10.1016/0003-4975(92)90082-f.

  PMID: 1449299 BACKGROUND

• Radmehr H, Soleimani A, Tatari H, Salehi M. Does combined antegrade-retrograde cardioplegia have any superiority over antegrade cardioplegia? Heart Lung Circ. 2008 Dec;17(6):475-7. doi: 10.1016/j.hlc.2008.04.009. Epub 2008 Jul 26.

  PMID: 18676202 BACKGROUND

• Guyton RA, Thourani VH, Puskas JD, Shanewise JS, Steele MA, Palmer-Steele CL, Vinten-Johansen J. Perfusion-assisted direct coronary artery bypass: selective graft perfusion in off-pump cases. Ann Thorac Surg. 2000 Jan;69(1):171-5. doi: 10.1016/s0003-4975(99)01386-7.

  PMID: 10654508 RESULT

• Lu F, Ji BY, Liu JP, Liu MZ, Wang GY, Hu SS. Passive graft perfusion in off-pump coronary artery bypass grafting. Chin Med J (Engl). 2007 Feb 5;120(3):192-6.

  PMID: 17355820 RESULT

• Vassiliades TA Jr, Nielsen JL, Lonquist JL. Coronary perfusion methods during off-pump coronary artery bypass: results of a randomized clinical trial. Ann Thorac Surg. 2002 Oct;74(4):S1383-9. doi: 10.1016/s0003-4975(02)03912-7.

  PMID: 12400822 RESULT

• Goldman BS, Ovil Y, Mycyk T. A technique for selective graft perfusion during aortocoronary bypass. J Card Surg. 1987 Dec;2(4):495-8. doi: 10.1111/j.1540-8191.1987.tb00206.x.

  PMID: 2979995 RESULT

• Onem G, Sacar M, Baltalarli A, Ozcan AV, Gurses E, Sungurtekin H. Comparison of simultaneous antegrade/vein graft cardioplegia with antegrade cardioplegia for myocardial protection. Adv Ther. 2006 Nov-Dec;23(6):869-77. doi: 10.1007/BF02850208.

  PMID: 17276955 RESULT

• Gürsoy M, Bakuy V, Hatemi AC. Delivering Cardioplegia Beyond Totally Occluded Native Coronary Arteries Through the Saphenous Bypass Vein Graft: Is It Really a Protective Technique? Kosuyolu Kalp Derg. 2012;15:100 -104

  RESULT

• Hatemi AC, Ulusoy RfE, Gürsoy M, Tongut A. Myocardial Protection with Simultaneous Antegrade/Vein Graft Cardioplegia Compared to Antegrade Cardioplegia Alone in Elective Coronary Artery Bypass Grafting Patients. Balkan Medical Journal. 2011

  RESULT

• Goncu MT, Sezen M, Toktas F, Ari H, Gunes M, Tiryakioglu O, Yavuz S. Effect of antegrade graft cardioplegia combined with passive graft perfusion in on-pump coronary artery bypass grafting. J Int Med Res. 2010 Jul-Aug;38(4):1333-42. doi: 10.1177/147323001003800415.

  PMID: 20926006 RESULT

Results Point of Contact

• Title: Dr. Muhammad Sher-i-Murtaza
• Organization: Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakistan.

sherm.cpeic@gmail.com

0333-6107570

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior registrar cardiac surgery, Multan institute of cardiology, multan, pakistan.

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 1, 2014
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 9, 2021
• Results First Posted: December 8, 2014

Record last verified: 2021-02