The Role of Modified Ultrafiltration Following Open Heart Surgery
NCT ID: NCT06085066
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2021-12-01
2024-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Conventional Ultrafiltration alone on Cardiopulmonary bypass
Conventional ultrafiltration was used on a cardiopulmonary bypass procedure for patients who underwent open heart surgery
Conventional Ultrafiltration alone on Cardiopulmonary bypass
Conventional Ultrafiltration was used on Cardiopulmonary bypass for patients who underwent open heart surgery
Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass
Modified ultrafiltration was used following the conventional ultrafiltration on cardiopulmonary bypass procedure for patients who underwent open heart surgery
Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass
Modified Ultrafiltration was used following the Conventional Ultrafiltration on Cardiopulmonary bypass for patients who underwent open heart surgery
Interventions
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Conventional Ultrafiltration alone on Cardiopulmonary bypass
Conventional Ultrafiltration was used on Cardiopulmonary bypass for patients who underwent open heart surgery
Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass
Modified Ultrafiltration was used following the Conventional Ultrafiltration on Cardiopulmonary bypass for patients who underwent open heart surgery
Eligibility Criteria
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Inclusion Criteria
* Willing to become a research participant and sign an informed consent statement
Exclusion Criteria
* Patients that have immune disease, chronic lung disease, undergoing hemodialysis
* Patients who are pregnant
Drop-out Criteria
* Patients who experience repeated back-on bypass
* Patients who experience reopen surgery 24 hours after surgery
* Patients who die within 24 hours after surgery
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Ratna Farida Soenarto
Consultant, Anestesiologist, Principal Investigator
Principal Investigators
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Ratna F Soenarto, Consultant
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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Mahmoud AB, Burhani MS, Hannef AA, Jamjoom AA, Al-Githmi IS, Baslaim GM. Effect of modified ultrafiltration on pulmonary function after cardiopulmonary bypass. Chest. 2005 Nov;128(5):3447-53. doi: 10.1378/chest.128.5.3447.
Luciani GB, Menon T, Vecchi B, Auriemma S, Mazzucco A. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation. 2001 Sep 18;104(12 Suppl 1):I253-9. doi: 10.1161/hc37t1.094931.
Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.
Chandler HK, Kirsch R. Management of the Low Cardiac Output Syndrome Following Surgery for Congenital Heart Disease. Curr Cardiol Rev. 2016;12(2):107-11. doi: 10.2174/1573403x12666151119164647.
Suleiman MS, Zacharowski K, Angelini GD. Inflammatory response and cardioprotection during open-heart surgery: the importance of anaesthetics. Br J Pharmacol. 2008 Jan;153(1):21-33. doi: 10.1038/sj.bjp.0707526. Epub 2007 Oct 22.
Young RW. Prevention of lung injury in cardiac surgery: a review. J Extra Corpor Technol. 2014 Jun;46(2):130-41.
Paparella D, Yau TM, Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 Feb;21(2):232-44. doi: 10.1016/s1010-7940(01)01099-5.
Bronicki RA, Hall M. Cardiopulmonary Bypass-Induced Inflammatory Response: Pathophysiology and Treatment. Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S272-8. doi: 10.1097/PCC.0000000000000759.
Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24.
Atkins BZ, Danielson DS, Fitzpatrick CM, Dixon P, Petersen RP, Carpenter AJ. Modified ultrafiltration attenuates pulmonary-derived inflammatory mediators in response to cardiopulmonary bypass. Interact Cardiovasc Thorac Surg. 2010 Nov;11(5):599-603. doi: 10.1510/icvts.2010.234344. Epub 2010 Aug 3.
Sheikhi MA, Ebadi A, Shahriary A, Davoodzadeh H, Rahmani H. Cardiac Surgery Anesthesia And Systemic Inflammatory Response. Int J Bioassays. 2015;4(2):3648-3655. doi: 10.21746/ijbio.2015.02.005.
Muller-Werdan U, Prondzinsky R, Werdan K. Effect of inflammatory mediators on cardiovascular function. Curr Opin Crit Care. 2016 Oct;22(5):453-63. doi: 10.1097/MCC.0000000000000345.
Chew MS, Brix-Christensen V, Ravn HB, Brandslund I, Ditlevsen E, Pedersen J, Hjortholm K, Hansen OK, Tonnesen E, Hjortdal VE. Effect of modified ultrafiltration on the inflammatory response in paediatric open-heart surgery: a prospective, randomized study. Perfusion. 2002 Sep;17(5):327-33. doi: 10.1191/0267659102pf595oa.
Ziyaeifard M, Alizadehasl A, Aghdaii N, Rahimzadeh P, Masoumi G, Golzari SE, Fatahi M, Gorjipur F. The effect of combined conventional and modified ultrafiltration on mechanical ventilation and hemodynamic changes in congenital heart surgery. J Res Med Sci. 2016 Nov 7;21:113. doi: 10.4103/1735-1995.193504. eCollection 2016.
Perez-Vela JL, Ruiz-Alonso E, Guillen-Ramirez F, Garcia-Maellas MT, Renes-Carreno E, Cerro-Garcia M, Cortina-Romero J, Hernandez-Rodriguez I. ICU outcomes in adult cardiac surgery patients in relation to ultrafiltration type. Perfusion. 2008 Mar;23(2):79-87. doi: 10.1177/0267659108095167.
Papadopoulos N, Bakhtiary F, Grun V, Weber CF, Strasser C, Moritz A. The effect of normovolemic modified ultrafiltration on inflammatory mediators, endotoxins, terminal complement complexes and clinical outcome in high-risk cardiac surgery patients. Perfusion. 2013 Jul;28(4):306-14. doi: 10.1177/0267659113478450. Epub 2013 Feb 19.
Onoe M, Magara T, Yamamoto Y, Nojima T. Modified ultrafiltration removes serum interleukin-8 in adult cardiac surgery. Perfusion. 2001 Jan;16(1):37-42. doi: 10.1177/026765910101600106.
Other Identifiers
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IndonesiaUAnes1000
Identifier Type: -
Identifier Source: org_study_id
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