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Completed

NCT Number: NCT06085066

The Role of Modified Ultrafiltration Following Open Heart Surgery

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.

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Key information

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Ultrafiltration alone on Cardiopulmonary bypass

Procedure

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

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

Primary outcomes

  1. Interleukin-6

    Time frame: 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.

  2. Systemic Vascular Resistance (SVR)

    Time frame: 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.

  3. Pulmonary Vascular Resistance (PVR)

    Time frame: 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.

  4. Cardiac Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 16, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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