The Role of Modified Ultrafiltration Following Open Heart Surgery

University of Indonesia (UI)

Status: Completed

Conditions: Heart; Surgery, Heart, Functional Disturbance as Result

Treatments: Procedure: Conventional Ultrafiltration alone on Cardiopulmonary bypass; Procedure: Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT06085066

IndonesiaUAnes1000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

• Patients who experience repeated back-on bypass
• Patients who experience reopen surgery 24 hours after surgery
• Patients who die within 24 hours after surgery

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

38 participants in 2 patient groups

Conventional Ultrafiltration alone on Cardiopulmonary bypass

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Ultrafiltration alone on Cardiopulmonary bypass

Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass