Fluid Responsiveness in Post Cardiac Surgery Patients

NCT06583200 | Enrolling By Invitation DMC

• 1 other identifier: FAMSU MD 220/2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.

Conditions

Cardiac Complication

Keywords

Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Predictive value of EEO and passive leg raising

  Predictive value of EEO and passive leg raising to fluid responsiveness in post cardiac surgery mechanically ventilated patients Pulse pressure variation before and after passive leg raising test

  One year

Secondary Outcomes (2)

• Arterial blood pressure

  One year

• Heart rate

  One year

Other Outcomes (1)

• Central venous pressure

  One year

Study Arms (2)

End Expiratory Occlusion Test

OTHER

Pulse pressure variation before and after end expiratory occlusion test

Diagnostic Test: End Expiratory Occlusion Test; Diagnostic Test: Passive Leg Raising Test

Passive leg raising test

OTHER

Pulse pressure variation before and after passive leg raising test

Diagnostic Test: End Expiratory Occlusion Test; Diagnostic Test: Passive Leg Raising Test

Interventions

End Expiratory Occlusion Test DIAGNOSTIC_TEST

All studied mechanically ventilated patients under post operative sedation. EEO test will be applied to predict probable responder and probable non-responder according to pulse pressure variation in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of 5% or more

End Expiratory Occlusion Test; Passive leg raising test

Passive Leg Raising Test DIAGNOSTIC_TEST

All studied mechanically ventilated patients under post operative sedation.Passive leg raising test will be applied to predict probable responder and probable non-responder according to the PPV in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of at least 10%

End Expiratory Occlusion Test; Passive leg raising test

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age group: 21-60years old
• Sex: eligible both sexes
• Post cardiac surgery
• Sedated intubated mechanically ventilated patients (Controlled ventilation with no respiratory effort)

You may not qualify if:

• Patients refusal
• Pregnancy or any medical condition that may affect the intra abdominal pressure.
• Lower limb deep venous thrombosis Open chest conditions impaired left-ventricular ejection fraction (\<45%), arrhythmias, inter-ventricular shunt, severe peripheral arterial occlusive disease and the need for intra-aortic balloon counter pulsation

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine Ain Shams University

Cairo, Cairo Governorate, 000, Egypt

Location

Study Officials

• Marwa Khairy, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 12, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-04

Locations

EG (1)