Acute Normovolemic Hemodilution in Off-pump CABG

Acute Normovolemic Hemodilution Clinical Trial

Official title:

Acute Normovolemic Hemodilution Using Hydroxyethyl Starch (HES 130/0.4) in Patients Undergoing Off-pump Coronary Artery Bypass Grafting Surgery: Effects on Central and Peripheral Perfusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042883
• Other study ID #: Hemodilution off-pump CABG
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2019
• Est. completion date: April 15, 2020

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: Hany M. Osman, M.D.
• Phone: +201002414591
• Email: hanymeo[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery

Description:

Off‑pump coronary artery bypass surgery is an alternative to conventional coronary artery bypass grafting using cardiopulmonary bypass (CPB). It avoids adverse effects of CPB such as systemic inflammatory response, impaired myocardial protection, and air or plaque embolism. However, OPCAB surgery involves displacement and manipulation of the heart to expose target coronary arteries. These manipulations cause hemodynamic instability as a result of transient annulo‑mitral distortion and acute mitral regurgitation, compression of the right ventricle, and impaired cardiac contractility due to epicardial stabilizers. signs of impaired perfusion such as metabolic acidosis, increased serum lactate and decreased urine output are commonly seen intraoperatively

Excessive surgical bleeding causes hypovolemia and hemodynamic instability, anemia, and reduced oxygen delivery to tissues

Acute normovolemic hemodilution (ANH) is an alternative method of management of intraoperative blood loss, in which a certain volume of blood is collected from the patient, stored at room temperature and replaced by an equal volume of colloid solution. By the end of surgery, this blood is returned to the patient, usually within eight hours of collection, with little deterioration of platelets or coagulation factors

This work aims to study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for off- pump CABG surgery

Exclusion Criteria:

• Ejection fraction less than 40%

• Hematocrit less than 11 g/dl

• patients with severe renal impairment

Related Conditions & MeSH terms

• Acute Normovolemic Hemodilution
• Off-Pump Coronary Artery Bypass Surgery

Intervention

Procedure:
• Acute normovolemic hemodilution
500 ml of blood will be taken from the patient with simultaneous replacement with hydroxyethyl starch (HES 130/0.4) in another IV line

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central venous oxygen saturation	Central venous blood gas analysis	Intraoperative
Primary	The perfusion index	perfusion index derived from pulseoximetry	Intraoperative
Primary	Serum lactate	from arterial blood gas analysis	Intraoperative