Bypass ComplicationNCT03072784
Aortic Cross Clamping Time, and Postoperative Respiratory Function
A study testing aortic cross clamping in people with Bypass Complication and Respiratory Complication, run by Assiut University at 1 site in Egypt.
Trial summary
Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post operative pulmonary function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bypass Complication, Respiratory Complication
- What is being tested?
- aortic cross clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2015to 25 Aug 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patients
- elective open heart surgery
Who cannot join
- Patients with myocardial ischemia or previous infarction
- low ejection fraction <30%
- history of AF
- implanted pacemaker
- uncontrolled hypertension
- renal impairment (creatinine >1.8 mg/dl)
Show all 9Show fewer
- hepatic dysfunction
- insulin dependent diabetes
- chronic pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implication of Aortic Cross Clamping Time Upon Postoperative Respiratory Function in Adult Patients Undergoing Open Heart Surgery
Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post operative pulmonary function.
Read the detailed description
Cardiac surgery usually is done under cardiopulmonary bypass. As the blood contacts with the artificial tubing of the circuit, there is release of mediators which affects pulmonary function. Of no doubt that the duration of cardiopulmonary bypass, and cross clamping time, will affect the spell over of such mediators. Follow up of the pulmonary function, and arterial blood gas is mandatory in such group of patients.
- Conditions
- Bypass Complication, Respiratory Complication
- Being tested
- aortic cross clamping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic cross clampingProcedure or surgery
duration of cross clamping, less than 90 minutes, or more than 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| group S | Active comparator | short time <90 m aortic cross clamping Receives: Procedure: aortic cross clamping |
| group L | Active comparator | > 90 minutes aortic cross clamping Receives: Procedure: aortic cross clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of oxygenation
PaO2 mmHg
Measured: 48 hours postoperative
Secondary outcomes (3)
time to extubation
time to extubate in minutes
Measured: 24 hours postoperative
ventilation
respiratory rate (breath/minute)
Measured: 48 hours postoperative
carbon dioxide
PaCO2 mmhg
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Feb 2015
- Primary completion20 Apr 2016
- Study completion25 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bypass ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
- Investigators
- Emad Z kamel Said, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072784
- Sponsor's protocol ID
- IRB00009915
- Status last verified
- Mar 2017
- First submitted
- 15 Feb 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Aortic Cross Clamping Time Upon Postoperative Respiratory Function in Adult Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT03072784
- Acronym / sponsor ID
- IRB00009915
- Conditions
- Bypass Complication, Respiratory Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 20 Apr 2016 (actual)
- Study completion
- 25 Aug 2016 (actual)
- First posted
- 7 Mar 2017 (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.
Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post operative pulmonary function.
Detailed description
Cardiac surgery usually is done under cardiopulmonary bypass. As the blood contacts with the artificial tubing of the circuit, there is release of mediators which affects pulmonary function. Of no doubt that the duration of cardiopulmonary bypass, and cross clamping time, will affect the spell over of such mediators. Follow up of the pulmonary function, and arterial blood gas is mandatory in such group of patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group S | Active comparator | Procedure: aortic cross clampingshort time <90 m aortic cross clamping |
| group L | Active comparator | Procedure: aortic cross clamping> 90 minutes aortic cross clamping |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients
- elective open heart surgery
Key exclusion criteria (9 listed)
- Patients with myocardial ischemia or previous infarction
- low ejection fraction <30%
- history of AF
- implanted pacemaker
- uncontrolled hypertension
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 |
|---|---|---|
| aortic cross clampingduration of cross clamping, less than 90 minutes, or more than 90 minutes | Procedure or surgery | group L, group S |
Primary outcome
quality of oxygenation
Time frame: 48 hours postoperative
PaO2 mmHg
3 secondary outcomes
time to extubation
Time frame: 24 hours postoperative
ventilation
Time frame: 48 hours postoperative
carbon dioxide
Time frame: 48 hours
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 9 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Bypass Complication
Not yet recruitingObservational study
Epigenetic Susceptibility to Inflammatory Complications After Cardiac Surgery
Organ Dysfunction, Inflammation in Cardiac Surgery
Not yet recruitingObservational study
PCO₂ Gap and Lactate as Predictors of POCD After Cardiac Surgery
Postoperative Cognitive Dysfunction (POCD), Cardiac Surgery
Active, not recruiting
Early Outcomes of Spontaneous vs. Negative-pressure Drainage After Coronary Artery Bypass Grafting
Drainage, Complications Due to Coronary Artery Bypass Graft
Not yet recruitingObservational study
Erector Spinae Oxygen Saturation and AKI After OPCAB
Acute Kidney Injury, Coronary Artery Disease
Not yet recruitingObservational study
Mechanical Power and Pulmonary Complications in CABG Surgery
Postoperative Pulmonary Complications, Coronary Artery Bypass Graft Surgery (CABG)
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.
Emad Z kamel Said, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aortic cross clamping in people with Bypass Complication and Respiratory Complication, run by Assiut 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 2 inclusion and 9 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 9 Mar 2017. 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?
quality of oxygenation (time frame: 48 hours postoperative). 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 9 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.