Fluid OverloadNCT05957003
Fluid Responsiveness in Post-cardiac Surgery
A study testing Combined end-expiratory occlusion and end-inspiratory occlusion test and Tidal volume challenge test in people with Fluid Overload and Cardiac Surgery, run by Tanta University at 1 site in Egypt.
Trial summary
the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Cardiac Surgery, Postoperative Complications
- What is being tested?
- Combined end-expiratory occlusion and end-inspiratory occlusion test and Tidal volume challenge test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on mechanical ventilation
- Patients ≥18 years of age
- patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)
- patients with normal systolic function of the left and right ventricle
- patient is mechanically ventilated with a protective lung strategy
Who cannot join
- Patients with Spontaneously breathing activity
- Patients undergoing emergent cardiac surgery.
- Patient with severe peripheral arterial occlusive disease
- Pregnant women
- Contraindication of passive leg raising test
- unstable post-operative course
Show all 10Show fewer
- Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications;
- presence of residual severe tricuspid or any valvular regurgitations
- low cardiac output, low ejection fractions (EF ≤45%)
- open chest,Pao2/Fio2 ≤ 200
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients
the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients
Read the detailed description
multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.
Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.
- Conditions
- Fluid Overload, Cardiac Surgery, Postoperative Complications
- Being tested
- Combined end-expiratory occlusion and end-inspiratory occlusion test, Tidal volume challenge test
- Medical subject headings
- Edema, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined end-expiratory occlusion and end-inspiratory occlusion testProcedure or surgery
The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 seconds using the end-expiratory hold button available on the ventilator.
The EIO test will be performed by interrupting the mechanical ventilation at end-inspiration over 15 seconds using the end-inspiratory hold button available on the ventilator.
Tidal volume challenge testProcedure or surgery
elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| occlusions test | Active comparator | Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO Receives: Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test |
| challenge test | Active comparator | Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute) Receives: Procedure: Tidal volume challenge test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of volume responder participants could be detected using each fluid responsiveness test
The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test
Measured: immediate postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start10 Aug 2023
- Primary completion20 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957003
- Sponsor's protocol ID
- fluid responsiveness
- Status last verified
- Nov 2025
- First submitted
- 14 Jul 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05957003
- Acronym / sponsor ID
- fluid responsiveness
- Conditions
- Fluid Overload, Cardiac Surgery, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients
Detailed description
multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.
Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occlusions test | Active comparator | Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion testCombined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO |
| challenge test | Active comparator | Procedure: Tidal volume challenge testTidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients on mechanical ventilation
- Patients ≥18 years of age
- patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)
- patients with normal systolic function of the left and right ventricle
- patient is mechanically ventilated with a protective lung strategy
Key exclusion criteria (10 listed)
- Patients with Spontaneously breathing activity
- Patients undergoing emergent cardiac surgery.
- Patient with severe peripheral arterial occlusive disease
- Pregnant women
- Contraindication of passive leg raising test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined end-expiratory occlusion and end-inspiratory occlusion testThe EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 seconds using the end-expiratory hold button available on the ventilator. The EIO test will be performed by interrupting the mechanical ventilation at end-inspiration over 15 seconds using the end-inspiratory hold button available on the ventilator. | Procedure or surgery | occlusions test |
| Tidal volume challenge testelevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds | Procedure or surgery | challenge test |
Primary outcome
The number of volume responder participants could be detected using each fluid responsiveness test
Time frame: immediate postoperative period
The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Fluid Overload
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
RecruitingObservational study
Using Bioimpedance Analysis to Monitor Fluid Status in Children
Fluid Overload
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Enrolling by invitationObservational study
Blood Volume Monitoring Via Critline in Volume Overload: Hospitalization and Readmission
End Stage Renal Disease (ESRD), Volume Overload
Not yet recruiting
Boston Medical Center Ultrasound Decongestion Study in Heart Failure
Congestive Heart Failure, Volume Overload
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined end-expiratory occlusion and end-inspiratory occlusion test and Tidal volume challenge test in people with Fluid Overload and Cardiac Surgery, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of volume responder participants could be detected using each fluid responsiveness test (time frame: immediate postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.