Fluid TherapyfluidresponseNCT06249568
Evaluation of Fluid Responsiveness With Recruitment Maneuver After Sternotomy in Coronary Artery Bypass Surgery
An observational study of Fluid Therapy and Coronary Artery Bypass Surgery Patients, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Assuming that the basic reliability of dynamic indices will increase with the application of functional hemodynamic tests after sternotomy and protective lung ventilation in patients undergoing elective coronary artery bypass surgery, it is useful to predict fluid responsiveness after sternotomy in coronary artery… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Therapy, Coronary Artery Bypass Surgery Patients, Lung Recruitment Maneuver
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 20 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia
Who may be able to join
- 1-ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia
Who cannot join
- 1. Be younger than 18 years old, be over 80 years old
- 2. Patients with an ASA score greater than 3
- 3. EF<40%
- 4. Those with contraindications to anesthetic drugs
- 5. Patients with BMI>30
- 6. Patients who did not want to participate in the study
Show all 13Show fewer
- 7. Right ventricular dysfunction
- 8. COPD(Chronic obstructive pulmonary disease)
- 9. Bullous lung disease
- 10. Moderate to severe PHT
- 11. Severe kidney or liver disease
- 12. Patients with hemodynamic instability in the perioperative period
- 13. Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
ümit karadeniz, +905326025264, ukaradenzi2003@gmail.com
About this study
Assuming that the basic reliability of dynamic indices will increase with the application of functional hemodynamic tests after sternotomy and protective lung ventilation in patients undergoing elective coronary artery bypass surgery, it is useful to predict fluid responsiveness after sternotomy in coronary artery bypass surgery patients ventilated with 6 ml/kg PBW (ideal body weight). We aimed to reveal the sensitivity and specificity of PPV and SVV changes by applying a lung opening maneuver.
Read the detailed description
In order to evaluate the fluid deficit in patients undergoing coronary artery bypass surgery, researchers will measure stroke volume index, cardiac index and mean arterial pressure while the patients are in the lima position.
Then researchers will perform a lung opening maneuver (30mmHg for 30 seconds) and measure again.
researchers will measure again after the values return to normal. researchers will give patients balanced fluid at 3ml/kg and record their values.
Can researchers predict fluid response with lung opening maneuver?
- Keywords
- fluid therapy, Coronary Artery Bypass Surgery Patients, Lung Recruitment Maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who will have coroner arter bypass surgeon | Patients undergoing coronary artery bypass surgery will be eliminated if there are exclusion criteria. Patients who do not have exclusion criteria will be included in the study if they agree to volunteer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of fluid responsiveness in patients undergoing coronary arter bypass surgery.
: Demonstration of fluid responsiveness in patients who will undergo coronary artery bypass surgery will prevent unnecessary fluid administration in case of hemodynamic disturbance, and medical treatments and interventions can be performed in a timely and targeted manner. Researchers will perform a recruitment maneuver on the patients and record mean arterial pressure and stroke volume index.
Researchers will perform a recruitment maneuver on the patients and record mean arterial pressure and stroke volume index.
Afterwards, researchers will give 3ml/cc balanced fluid to the patient and record the change in mean arterial pressure and stroke volume index.
Measured: from start to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jun 2023
- Primary completion2 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Sakman Yılmaz, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249568
- Sponsor's protocol ID
- E2-23-3460
- Acronym
- fluidresponse
- Status last verified
- Jul 2024
- First submitted
- 13 Jan 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: fluid responsiveness
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluid Responsiveness With Recruitment Maneuver After Sternotomy in Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT06249568
- Acronym / sponsor ID
- fluidresponse / E2-23-3460
- Keywords
- fluid therapy, Coronary Artery Bypass Surgery Patients, Lung Recruitment Maneuver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 2 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 8 Feb 2024 (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.
Assuming that the basic reliability of dynamic indices will increase with the application of functional hemodynamic tests after sternotomy and protective lung ventilation in patients undergoing elective coronary artery bypass surgery, it is useful to predict fluid responsiveness after sternotomy in coronary artery bypass surgery patients ventilated with 6 ml/kg PBW (ideal body weight). We aimed to reveal the sensitivity and specificity of PPV and SVV changes by applying a lung opening maneuver.
Detailed description
In order to evaluate the fluid deficit in patients undergoing coronary artery bypass surgery, researchers will measure stroke volume index, cardiac index and mean arterial pressure while the patients are in the lima position.
Then researchers will perform a lung opening maneuver (30mmHg for 30 seconds) and measure again.
researchers will measure again after the values return to normal. researchers will give patients balanced fluid at 3ml/kg and record their values.
Can researchers predict fluid response with lung opening maneuver?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who will have coroner arter bypass surgeon | – | –Patients undergoing coronary artery bypass surgery will be eliminated if there are exclusion criteria. Patients who do not have exclusion criteria will be included in the study if they agree to volunteer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia
Key inclusion criteria (1 listed)
- 1-ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia
Key exclusion criteria (13 listed)
- 1. Be younger than 18 years old, be over 80 years old
- 2. Patients with an ASA score greater than 3
- 3. EF<40%
- 4. Those with contraindications to anesthetic drugs
- 5. Patients with BMI>30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of fluid responsiveness in patients undergoing coronary arter bypass surgery.
Time frame: from start to 4 months
: Demonstration of fluid responsiveness in patients who will undergo coronary artery bypass surgery will prevent unnecessary fluid administration in case of hemodynamic disturbance, and medical treatments and interventions can be performed in a timely and targeted manner. Researchers will perform a recruitment maneuver on the patients and record mean arterial pressure and stroke volume index. Researchers will perform a recruitment maneuver on the patients and record mean arterial pressure and stroke volume index. Afterwards, researchers will give 3ml/cc balanced fluid to the patient and record the change in mean arterial pressure and stroke volume index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No. fluid responsiveness
Related trials for Fluid Therapy
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Therapy and Coronary Artery Bypass Surgery Patients, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact meltem sakman yılmaz (+90 505 922 1049, meltemsakmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of fluid responsiveness in patients undergoing coronary arter bypass surgery. (time frame: from start to 4 months). 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 16 Jul 2024.