The Role of Modified Ultrafiltration Following Open Heart Surgery

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT06085066

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart; Surgery, Heart, Functional Disturbance as Result	Procedure: Conventional Ultrafiltration alone on Cardiopulmonary bypass Procedure: Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

The Role of Modified Ultrafiltration on Vascular Resistance, Cardiac Index Enhancement, and Inflammation Reduction Following Open Heart Surgery; A Randomized Clinical Trial

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Ultrafiltration alone on Cardiopulmonary bypass 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 was used on Cardiopulmonary bypass for patients who underwent open heart surgery
Active Comparator: 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	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: Conventional Ultrafiltration alone on Cardiopulmonary bypass

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

Active Comparator: 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

Procedure: 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

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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