Cardioplegia Solution Adverse ReactionNCT04306913
Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study
A study testing Esmolol and Potassium Cardioplegic Solution in people with Cardioplegia Solution Adverse Reaction, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Perioperative myocardial injury remains one of the most serious complications of cardiac surgery. Numerous factors have been implicated during the pathogenesis process, including the technique of cardiac surgery, induction of cardioplegia and period of cardiac arrest. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Cardioplegia Solution Adverse Reaction
- What is being tested?
- Esmolol and Potassium Cardioplegic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2020to Sep 2020
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-50 years old patients, with either sex with solitary valvular disease
Who cannot join
- • Myocardial infarction within 2 weeks.
- History of reaction or toxicity to esmolol or other beta blockers.
- New York Heart Association class IV congestive heart failure despite treatment.
- Persistent hypotension (systolic blood pressure <80 mm Hg).
- severe pulmonary hypertension
- Ejection fraction less than 45%
Show all 13Show fewer
- Patients with coronary artery disease
- Patients with congenital heart disease
- Patients with previous cardiac surgery
- Patients with liver disease (child class B and C)
- Patients with second or third degree heart block
- Patients having resting heart rate less than 50 ppm
- Patients using calcium channel blockers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr alainy medical school
Cairo, 12566
Noha sameh, 01224498481, drnohnoh91@gmail.com
About this study
Perioperative myocardial injury remains one of the most serious complications of cardiac surgery.
Numerous factors have been implicated during the pathogenesis process, including the technique of cardiac surgery, induction of cardioplegia and period of cardiac arrest.
Read more
Lactic acid is the normal endpoint of the anaerobic breakdown of glucose in the tissues. The lactate exits the cells and is transported to the liver, thus it's considered to be an indicator of ischemia as it is produced by most tissues in the human body, with the highest level of production found in muscle.
In any cardiac valve replacement surgery, patient must undergo cardiac bypass and arrest in diastole by using hyperkalemic cardioplegia solution; meanwhile the metabolism of myocardial cells is purely anaerobic.
Esmolol an ultra-short beta blocker is supposed to decrease the anaerobic insult to the myocardial cells.
- Conditions
- Cardioplegia Solution Adverse Reaction
- Being tested
- Esmolol, Potassium Cardioplegic Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
esmolol 250 mg in cardioplegia solution every 25 minutes
Potassium Cardioplegic SolutionDrug
15 meq potassium added to cardioplegia solution
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Drug: Potassium Cardioplegic Solution |
| Esmolol | Experimental | Not described Receives: Drug: Esmolol; Drug: Potassium Cardioplegic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary sinus lactate level immediately before declamping the aorta.
the lactate from the coronary sinus
Measured: 1 hour during declamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardioplegia Solution Adverse ReactionStudies 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, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abougabal, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306913
- Sponsor's protocol ID
- D-47-2019
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scorsin M, Mebazaa A, Al Attar N, Medini B, Callebert J, Raffoul R, Ramadan R, Maillet JM, Ruffenach A, Simoneau F, Nataf P, Payen D, Lessana A. Efficacy of esmolol as a myocardial protective agent during continuous retrograde blood cardioplegia. J Thorac Cardiovasc Surg. 2003 May;125(5):1022-9. doi: 10.1067/mtc.2003.175.
PubMed 12771874Murtuza B, Pepper JR, Stanbridge RD, Darzi A, Athanasiou T. Does minimal-access aortic valve replacement reduce the incidence of postoperative atrial fibrillation? Tex Heart Inst J. 2008;35(4):428-38.
PubMed 19156237Kuhn-Regnier F, Natour E, Dhein S, Dapunt O, Geissler HJ, LaRose K, Gorg C, Mehlhorn U. Beta-blockade versus Buckberg blood-cardioplegia in coronary bypass operation. Eur J Cardiothorac Surg. 1999 Jan;15(1):67-74. doi: 10.1016/s1010-7940(98)00289-9.
PubMed 10077376
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04306913
- Acronym / sponsor ID
- D-47-2019
- Conditions
- Cardioplegia Solution Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 13 Mar 2020 (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.
Perioperative myocardial injury remains one of the most serious complications of cardiac surgery.
Numerous factors have been implicated during the pathogenesis process, including the technique of cardiac surgery, induction of cardioplegia and period of cardiac arrest.
Lactic acid is the normal endpoint of the anaerobic breakdown of glucose in the tissues. The lactate exits the cells and is transported to the liver, thus it's considered to be an indicator of ischemia as it is produced by most tissues in the human body, with the highest level of production found in muscle.
In any cardiac valve replacement surgery, patient must undergo cardiac bypass and arrest in diastole by using hyperkalemic cardioplegia solution; meanwhile the metabolism of myocardial cells is purely anaerobic.
Esmolol an ultra-short beta blocker is supposed to decrease the anaerobic insult to the myocardial cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Potassium Cardioplegic Solution |
| Esmolol | Experimental | Drug: Esmolol, Drug: Potassium Cardioplegic Solution |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20-50 years old patients, with either sex with solitary valvular disease
Key exclusion criteria (13 listed)
- • Myocardial infarction within 2 weeks.
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 |
|---|---|---|
| Esmololesmolol 250 mg in cardioplegia solution every 25 minutes | Drug | Esmolol |
| Potassium Cardioplegic Solution15 meq potassium added to cardioplegia solution | Drug | Control, Esmolol |
Primary outcome
Coronary sinus lactate level immediately before declamping the aorta.
Time frame: 1 hour during declamping
the lactate from the coronary sinus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 12771874Scorsin M, Mebazaa A, Al Attar N, Medini B, Callebert J, Raffoul R, Ramadan R, Maillet JM, Ruffenach A, Simoneau F, Nataf P, Payen D, Lessana A. Efficacy of esmolol as a myocardial protective agent during continuous retrograde blood cardioplegia. J Thorac Cardiovasc Surg. 2003 May;125(5):1022-9. doi: 10.1067/mtc.2003.175.
- Background: PubMed 19156237Murtuza B, Pepper JR, Stanbridge RD, Darzi A, Athanasiou T. Does minimal-access aortic valve replacement reduce the incidence of postoperative atrial fibrillation? Tex Heart Inst J. 2008;35(4):428-38.
- Background: PubMed 10077376Kuhn-Regnier F, Natour E, Dhein S, Dapunt O, Geissler HJ, LaRose K, Gorg C, Mehlhorn U. Beta-blockade versus Buckberg blood-cardioplegia in coronary bypass operation. Eur J Cardiothorac Surg. 1999 Jan;15(1):67-74. doi: 10.1016/s1010-7940(98)00289-9.
- Individual participant dataSharing planned: Undecided
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?
A study testing Esmolol and Potassium Cardioplegic Solution in people with Cardioplegia Solution Adverse Reaction, run by Kasr El Aini Hospital 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 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 13 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Abougabal, PHD (00201020671408, ayman.abouagabal@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary sinus lactate level immediately before declamping the aorta. (time frame: 1 hour during declamping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04306913, which also lists 3 linked publications.
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 13 Mar 2020.