NCT04042883

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 1, 2019

Last Update Submit

August 10, 2019

Conditions

Acute Normovolemic HemodilutionOff-Pump Coronary Artery Bypass Surgery

Keywords

Perfusion

Outcome Measures

Primary Outcomes (3)

  • Central venous oxygen saturation

    Central venous blood gas analysis

    Intraoperative

  • The perfusion index

    perfusion index derived from pulseoximetry

    Intraoperative

  • Serum lactate

    from arterial blood gas analysis

    Intraoperative

Study Arms (2)

ANH

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

No intervention

Interventions

Acute normovolemic hemodilutionPROCEDURE

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

Also known as: ANH
ANH

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for off- pump CABG surgery

You may not qualify if:

  • Ejection fraction less than 40%
  • Hematocrit less than 11 g/dl
  • patients with severe renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Central Study Contacts

Hany M. Osman, M.D.

CONTACT

+201002414591hanymeo@aun.edu.eg

Fatma N. Mohamed, M.D.

CONTACT

fatmanabil2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 2, 2019

Study Start

August 10, 2019

Primary Completion

April 15, 2020

Study Completion

April 15, 2020

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

EG(1)