The Role of Modified Ultrafiltration Following Open Heart Surgery

March 13, 2024 updated by: Ratna Farida Soenarto, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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.
24 hours
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.
24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Ratna F Soenarto, Consultant, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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