Skip to main content
OpenTrials
Completed

NCT Number: NCT06835257

Hemodynamic Management in Autologous Blood Collection for CABG Surgery

In this study, investigated the hemodynamic differences between patients who underwent acute normovolemic hemodilution during the Autologous Blood Collection procedure in coronary artery bypass graft surgery and those who did not, using hemodynamic and cardiac data obtained by MostCare's pressure recording analytical method (PRAM).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ataturk University, Erzurum, Yakutiye, Turkey (Türkiye)

Loading trial locations.

About this study

Coronary artery bypass graft (CABG) surgeries are surgeries in which the need for blood transfusion is high. Allogeneic transfusion and transfusion-related complications have led researchers to use different techniques. Autologous blood collection method is one of the alternative methods used to eliminate the need for transfusion. The acute normovolemic hemodilution technique traditionally applied during autologous blood collection causes hemodilution in CABG surgeries and increases the risk of bleeding in patients. In this study, vasopressor infusion technique was used as an alternative technique to avoid hemodilution during autologous blood collection. These two techniques (Acute normovolemic hemodilution - Vasopressor infusion) applied to maintain hemodynamic stabilization during autologous blood collection were compared with the advanced cardiac and hemodynamic data provided by the pressure recording analytical method. The primary aim of the study was to compare cardiac cycle efficiency (CCE), which is a cardiac performance parameter and provides estimates of the energy spent by the cardiovascular system to maintain hemodynamic balance. Secondary objectives are to compare other advanced hemodynamic and postoperative laboratory parameters.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age at least 18 years
  • Undergoing isolated coronary artery bypass grafting surgery under general anesthesia
  • Invasive blood pressure (radial or femoral) and Mostcare monitoring
  • Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery
  • Ability and willingness to provide informed consent

Exclusion criteria

  • Refuse to consent to the study
  • Arterial wave form distortion
  • Cardiac arrhythmia
  • Inappropriate identification of the dicrotic notch for any reason
  • Hemodynamic instability defined as mean arterial blood pressure < 65 mmHg
  • Preoperative requirement of inotrope/vasopressor infusion
  • Preoperatively receiving vasoactive drugs
  • Patients fitted with an intra-aortic balloon pump
  • Patients fitted with Extracorporeal Membrane Oxygenation
  • Critically ill patients requiring preoperative intensive care unit
  • Presence of intraabdominal hypertension
  • New York Heart Association Class 3-4 heart failure
  • Congestive heart failure with ejection fraction < 35%
  • Glomerular filtration rate < 30 ml/min/1.73 m2
  • Ongoing renal replacement therapy

Treatment and study plan

Acute normovolemic hemodilutions

Procedure

Crystalloid infusion throughout the autologous blood collection (3 ml of crystalloid infusion for every 1 ml of blood)

Vasopressor infusion

Drug

Vasopressor infusion throughout the autologous blood collection (according to mean arterial pressure)

Primary outcomes

  1. Comparison of the effects of different techniques used for autologous blood collection on Cardiac Cycle Efficiency (CCE) changes obtained by pulse contour analysis.

    Time frame: From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)

    Difference of Cardiac Cycle Efficiency(CCE) PRAM parameters between patients

Secondary outcomes

  1. Comparison of the Contractility (dP/dtmax mmHg/msec), Stroke Volume Index (SVI mL/m2), Cardiac Power Index (CPI W/m2), Arterial Elastance (Ea mmHg/mL), Stroke Volume Variation (SVV %), Pulse Pressure Variation (PPV %) changes

    Time frame: From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)

    Difference of other PRAM and traditional hemodynamic parameters between patients

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Evaluation of the Effect of Different Hemodynamic Managements Throughout Autologous Blood Collection Methods on Pulse Contour Analysis Parameters in Coronary Artery Bypass Graft Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

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.

Published trials that share one or more normalized conditions with this study.