Clinical trial NCT06085066: The Role of Modified Ultrafiltration Following Open Heart Surgery
Official title: The Role of Modified Ultrafiltration on Vascular Resistance, Cardiac Index Enhancement, and Inflammation Reduction Following Open Heart Surgery; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin-6
timeFrame: 24 hours
measure: Systemic Vascular Resistance (SVR)
timeFrame: 24 hours
measure: Pulmonary Vascular Resistance (PVR)
timeFrame: 24 hours
measure: Cardiac Index
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Ratna F Soenarto, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
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