Acute Normovolemic Hemodilution in Off-pump CABG

NCT ID: NCT04042883

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2020-04-15

Brief Summary

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

Detailed Description

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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

Conditions

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Acute Normovolemic Hemodilution Off-Pump Coronary Artery Bypass Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Acute normovolemic hemodilution

Intervention Type PROCEDURE

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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ANH

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hany Mostafa Esmaeil Osman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hany M. Osman, M.D.

Role: CONTACT

+201002414591

Fatma N. Mohamed, M.D.

Role: CONTACT

Facility Contacts

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Hany M. Osman, M.D.

Role: primary

+201002414591

Fatma N. Mohamed, M.D.

Role: backup

Other Identifiers

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Hemodilution off-pump CABG

Identifier Type: -

Identifier Source: org_study_id

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