The Role of Modified Ultrafiltration Following Open Heart Surgery

Not Applicable

Completed

• Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
• Interventions: Procedure: Conventional Ultrafiltration alone on Cardiopulmonary bypass; Procedure: Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass

• Registration Number: NCT06085066
• Lead Sponsor: Indonesia University

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.

Detailed Description

The target of this study is adult patients diagnosed with coronary heart disease and valve disease who underwent open heart surgery in CICU PJT RSCM and Jakarta Heart Hospital. The research was conducted after obtaining approval from the FKUI-RSCM ethical committee, and the research subjects agreed to participate by signing an informed consent form. The anesthesia team prepared research subjects undergoing surgery with the placement of arterial cannulas, central venous catheters, sheath introducers, pulmonary artery catheters, and anesthesia management. The placement of these instruments aimed at measuring dependent variables studied included Systemic Vascular Resistance (SVR), Pulmonary Vascular Resistance (PVR), Cardiac Index (CI), and IL-6 levels. The CPB machine was used during the heart chamber opening procedure or coronary artery graft placement, and CUF was initiated. After CPB use was concluded, research subjects were allocated to either the control group or the treatment group through randomization. MUF was performed post-CPB in the treatment group, with the pump speed not exceeding 10% of full flow for 10 minutes. IL-6 levels were measured twice, namely before induction of anesthesia and 24 hours after CPB. SVR, PVR, and CI measurements were carried out before CPB, post-CPB, 10 minutes post-CPB, and 24 hours post-CPB.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-16
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Ultrafiltration alone on Cardiopulmonary bypass	Conventional Ultrafiltration alone on Cardiopulmonary bypass	Conventional ultrafiltration was used on a cardiopulmonary bypass procedure for patients who underwent open heart surgery
Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass	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

Primary Outcome Measures

Name	Time	Method
Interleukin-6	24 hours	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.
Pulmonary Vascular Resistance (PVR)	24 hours	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.
Systemic Vascular Resistance (SVR)	24 hours	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.
Cardiac Index	24 hours	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.

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia