The Role of Modified Ultrafiltration Following Open Heart Surgery

NCT06085066 | Completed

• 1 other identifier: IndonesiaUAnes1000
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of combining conventional ultrafiltration and modified ultrafiltration compared to conventional ultrafiltration alone in patients who underwent open heart surgery.

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Keywords

Cardiopulmonary bypass; Conventional ultrafiltration; Modified ultrafiltration; Systemic vascular resistance; Pulmonary vascular resistance; Cardiac output index; Interleukin-6

Outcome Measures

Primary Outcomes (4)

• Interleukin-6

  Comparison of IL-6 levels between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. IL-6 levels were assessed using blood samples drawn through a Central Venous Catheter installed before the procedure. Elevated IL-6 levels are indicative of heightened inflammation in the patient, correlating with a more adverse outcome.

  24 hours

• Systemic Vascular Resistance (SVR)

  Comparison of SVR between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. SVR is the aortic resistance value that the left heart must surpass to pump blood out effectively. SVR measurements are acquired by placing a Pulmonary Artery Catheter in the jugular vein, which is subsequently connected to a Philips monitor. This allows for automatic reading of SVR in dyne.sec/cm5 units through the monitor.

  24 hours

• Pulmonary Vascular Resistance (PVR)

  Comparison of PVR between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. PVR is the pulmonary artery resistance value that the right heart must surmount to efficiently pump blood out. PVR measurements are derived from the insertion of a Pulmonary Artery Catheter via the jugular vein, which is subsequently linked to a Philips monitor, facilitating automated readings in units of dyne.sec/cm5 through the monitor.

  24 hours

• Cardiac Index

  Comparison of Cardiac Index between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. The cardiac index (CI) represents the volume of blood continuously ejected from the left heart in one minute, relative to the body surface area. CI measurements are acquired through the insertion of a Pulmonary Artery Catheter via the jugular vein, which is subsequently linked to a Philips monitor. This allows for automatic readings in units of L/minute/m2. A higher CI value corresponds to a more favorable patient outcome.

  24 hours

Study Arms (2)

Conventional Ultrafiltration alone on Cardiopulmonary bypass

ACTIVE COMPARATOR

Conventional ultrafiltration was used on a cardiopulmonary bypass procedure for patients who underwent open heart surgery

Procedure: Conventional Ultrafiltration alone on Cardiopulmonary bypass

Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass

ACTIVE COMPARATOR

Modified ultrafiltration was used following the conventional ultrafiltration on cardiopulmonary bypass procedure for patients who underwent open heart surgery

Procedure: Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass

Interventions

Conventional Ultrafiltration alone on Cardiopulmonary bypass PROCEDURE

Conventional Ultrafiltration was used on Cardiopulmonary bypass for patients who underwent open heart surgery

Conventional Ultrafiltration alone on Cardiopulmonary bypass

Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass PROCEDURE

Modified Ultrafiltration was used following the Conventional Ultrafiltration on Cardiopulmonary bypass for patients who underwent open heart surgery

Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass

Eligibility Criteria

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

You may qualify if:

• Adult patients aged 18 years or older undergoing elective open heart surgery
• Willing to become a research participant and sign an informed consent statement

You may not qualify if:

• Patients undergoing redo surgery and emergency surgery
• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Location

Related Publications (17)

• 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.

  PMID: 16304298 BACKGROUND

• 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.

  PMID: 11568065 BACKGROUND

• 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.

  PMID: 27671216 BACKGROUND

• 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.

  PMID: 26585039 BACKGROUND

• 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.

  PMID: 17952108 BACKGROUND

• Young RW. Prevention of lung injury in cardiac surgery: a review. J Extra Corpor Technol. 2014 Jun;46(2):130-41.

  PMID: 25208430 BACKGROUND

• 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.

  PMID: 11825729 BACKGROUND

• 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.

  PMID: 27490610 BACKGROUND

• 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.

  PMID: 26116810 BACKGROUND

• 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.

  PMID: 20682630 BACKGROUND

• 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.

  PMID: 27857938 BACKGROUND

• 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.

  PMID: 27583586 BACKGROUND

• 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.

  PMID: 12243435 BACKGROUND

• 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.

  PMID: 28255321 BACKGROUND

• 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.

  PMID: 18840575 BACKGROUND

• 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.

  PMID: 23429100 BACKGROUND

• 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.

  PMID: 11192306 BACKGROUND

Study Officials

• Ratna F Soenarto, Consultant

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Anestesiologist, Principal Investigator

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 16, 2023
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)