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Acute Normovolemic Hemodilution in Off-pump CABG

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04042883
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
8.2
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Acute normovolemic hemodilution
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 10, 2019
Anticipated Primary Completion Date :
Apr 15, 2020
Anticipated Study Completion Date :
Apr 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ANH

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

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
Other Names:
  • ANH

    		•
    No Intervention: Control

    No intervention

    Outcome Measures

    Primary Outcome Measures

    1. Central venous oxygen saturation [Intraoperative]

      Central venous blood gas analysis

    2. The perfusion index [Intraoperative]

      perfusion index derived from pulseoximetry

    3. Serum lactate [Intraoperative]

      from arterial blood gas analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04042883
    Other Study ID Numbers:
    • Hemodilution off-pump CABG
    First Posted:
    Aug 2, 2019
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut University
    Perfusion

    Study Results

    No Results Posted as of Aug 13, 2019