NCT05945303

Brief Summary

Coronary artery bypass graft (CABG) surgery is one of the most frequently performed cardiac surgery procedures worldwide. CABG has been used for more than 40 years to relieve symptoms and to reduce the risk of death in patients with ischemic heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

July 6, 2023

Last Update Submit

October 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reliability of predicting fluid responsiveness

    to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.

    2 hours after the coronary artery bypass graft surgery

Secondary Outcomes (1)

  • Thoracic fluid content

    2 hours after the coronary artery bypass graft surgery

Study Arms (2)

Responder group

EXPERIMENTAL

About 20 Adult patients Planned for elective CABG surgery

Procedure: Coronary Artery Bypass Grafting surgery

Not Responder group

EXPERIMENTAL

About 20 Adult patients Planned for elective CABG surgery

Procedure: Coronary Artery Bypass Grafting surgery

Interventions

Assessing the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.

Not Responder groupResponder group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients (above 18 years old to be able to provide advanced informed consent Planned for elective CABG surgery) both male and female will be included in the study

You may not qualify if:

  • Severely reduced preoperative left ventricular ejection fraction (\< 40 %).
  • Patients who will develop any complication after fluid infusion as pulmonary edema and heart failure will be excluded from the study.
  • Significant cardiac arrhythmia.
  • Significant valvular heart disease.
  • Clinically evident pulmonary disease.
  • Bilaterally inserted venous catheters (jugular or subclavian vein).
  • History of radiotherapy or surgery of the neck region.
  • Inability to obtain interpretable ultrasound images due to a difficult acoustic window.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

Location

Study Officials

  • Mofeed Abdallah, Professor

    Al-Azhar University, Faculty of medicine for boys

    STUDY CHAIR
  • Mohamed Abdelgawad, Assist.Professor

    Department of Anesthesia,Faculty of Medicine,Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

March 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 30, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations