Hemodynamic Management in Autologous Blood Collection for CABG Surgery

NCT ID: NCT06835257

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-10-01

Brief Summary

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).

Detailed Description

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.

Conditions

Coronary Artery Bypass Grafting; Acute Normovolemic Hemodilution

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Acute normovolemic hemodilution

Acute normovolemic hemodilution throughout the autologous blood collection

Group Type: ACTIVE_COMPARATOR

Acute normovolemic hemodilutions

Intervention Type: PROCEDURE

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

Vasopressor

Vasopressor infusion throughout the autologous blood collection

Group Type: ACTIVE_COMPARATOR

Vasopressor infusion

Intervention Type: DRUG

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

Interventions

Acute normovolemic hemodilutions

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

Intervention Type: PROCEDURE

Vasopressor infusion

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed E Aydin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Bennett-Guerrero E, Zhao Y, O'Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA. 2010 Oct 13;304(14):1568-75. doi: 10.1001/jama.2010.1406.

Reference Type: BACKGROUND

PMID: 20940382 (View on PubMed)

Coursin DB, Monk TG. Extreme normovolemic hemodilution: how low can you go and other alternatives to transfusion? Crit Care Med. 2001 Apr;29(4):908-10. doi: 10.1097/00003246-200104000-00051. No abstract available.

Reference Type: BACKGROUND

PMID: 11373498 (View on PubMed)

Romano SM, Pistolesi M. Assessment of cardiac output from systemic arterial pressure in humans. Crit Care Med. 2002 Aug;30(8):1834-41. doi: 10.1097/00003246-200208000-00027.

Reference Type: BACKGROUND

PMID: 12163802 (View on PubMed)

Other Identifiers

ATATURK-Hemodynamic

Identifier Type: -

Identifier Source: org_study_id