Cardiac InfectionNCT06454643
Gentamicin in Cardiac Surgery
A study testing Flucloxacillin and gentamicin and Flucloxacillin and ceftriaxone in people with Cardiac Infection, run by Al-Rasheed University College at 1 site in Iraq.
Trial summary
Surgical site infection (SSI) is a serious postoperative complication after cardiac surgery that have a negative impact on a patient's health and survival. This study aims to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI with monitoring to the effective therapeutic level. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Infection
- What is being tested?
- Flucloxacillin and gentamicin and Flucloxacillin and ceftriaxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2020to 1 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The research included individuals of both genders.
- Patients aged 18 and above.
- Patients had undergone any type of cardiac surgery.
Who cannot join
- Patients having a prior diagnosis of organ failure.
- Patients already on antibiotics.
- Patients with elevated baseline renal function test before operation.
- Patients with contraindications to any of the prescribed medications were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacological and Clinical Aspects of Using Gentamicin in Cardiac Surgery
Surgical site infection (SSI) is a serious postoperative complication after cardiac surgery that have a negative impact on a patient's health and survival. This study aims to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI with monitoring to the effective therapeutic level.
Read the detailed description
Gentamicin is an aminoglycoside antibiotic that exhibits a wide range of antibacterial effects, mostly targeting Gram-negative bacteria, while its effectiveness against Gram-positive organisms is comparatively weaker. Gentamicin has significant efficacy against multidrug-resistant bacteria as well. Gentamicin is often used in conjunction with beta-lactam antibiotics to provide enhanced therapeutic efficacy via a synergistic effect, particularly in cases of Gram-positive and multidrug-resistant bacterial infections.
This study aims to evaluate the efficacy of administering gentamicin in combination with flucloxacillin as a pre-medication and for 48 hours after surgery in reducing the incidence of surgical site infections in patients undergoing cardiac surgeries, as compared to using a combination of ceftriaxone and flucloxacillin. Additionally, the study aimed to observes the therapeutic level of gentamicin required to achieve an effective concentration of the drug.
A prospective comparative study was conducted using an appropriate sample of 50 Iraqi patients undergone several types of cardiac surgeries.
A total of 50 patients (34 males and 16 females) between the ages of 18 and 75 were included in this study. These patients were admitted to the Surgical Department of the Iraqi Center for Heart Disease over a one-year period from January 2020 to January 2021. All patients underwent various types of cardiac surgery, such as coronary artery bypass graft (CABG), valve replacement, or device placement. The same surgical and anesthesia teams conducted the procedures.
A computerized randomization method was used to allocate patients into two groups in a randomized manner. Following the first interview, the patients were sequentially assigned numbers and then randomized into two groups via the online program Research Randomizer
- Conditions
- Cardiac Infection
- Being tested
- Flucloxacillin and gentamicin, Flucloxacillin and ceftriaxone
- Keywords
- infection, antibiotics, antimicrobial prophylaxis, aminoglycoside, Gentamicin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flucloxacillin and gentamicinDrug
This intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI.
Flucloxacillin and ceftriaxoneDrug
Control group
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients received flucloxacillin and ceftriaxone 60 minute before incision and then continued for 48 hours as follows:
* Flucloxacillin 2g given before surgery then 1g * 4 for 48 hours after operation.
* Ceftriaxone 1g given before surgery then 1g * 2 for 48 hours after operation. Receives: Drug: Flucloxacillin and ceftriaxone |
| Gentamicin | Experimental | Patients received flucloxacillin and gentamicin 60 minute before incision and then continued for 48 hours, as follows:
* Flucloxacillin 2g given before surgery then 1g * 4 for 48 hours after operation.
* Gentamicin 2mg/kg of ideal body weight given before surgery, then 80 mg *3 for 48 hours after surgery. Receives: Drug: Flucloxacillin and gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
White blood cells
White blood cells count (WBCs per microliter).
Measured: Up to 5 days post-surgery
Hemoglobin level
Hemoglobin concentration (g/dl).
Measured: Up to 5 days post-surgery.
Erythrocyte sedimentation rate
Erythrocyte sedimentation rate (millimeters per hour).
Measured: Up to 5 days post-surgery.
Body temperature
Body temperature measurement (Degrees Celsius °C).
Measured: Up to 5 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac InfectionStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454643
- Sponsor's protocol ID
- AR200311
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ackah JK, Neal L, Marshall NR, Panahi P, Lloyd C, Rogers LJ. Antimicrobial prophylaxis in adult cardiac surgery in the United Kingdom and Republic of Ireland. J Infect Prev. 2021 Mar;22(2):83-90. doi: 10.1177/1757177420971850. Epub 2020 Nov 24.
PubMed 33859725White RW, West R, Howard P, Sandoe J. Antimicrobial regime for cardiac surgery: the safety and effectiveness of short-course flucloxacillin (or teicoplanin) and gentamicin-based prophylaxis. J Card Surg. 2013 Sep;28(5):512-6. doi: 10.1111/jocs.12155. Epub 2013 Jul 9.
PubMed 23837413
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacological and Clinical Aspects of Using Gentamicin in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06454643
- Acronym / sponsor ID
- AR200311
- Conditions
- Cardiac Infection
- Keywords
- infection, antibiotics, antimicrobial prophylaxis, aminoglycoside, Gentamicin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Jun 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.
Surgical site infection (SSI) is a serious postoperative complication after cardiac surgery that have a negative impact on a patient's health and survival. This study aims to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI with monitoring to the effective therapeutic level.
Detailed description
Gentamicin is an aminoglycoside antibiotic that exhibits a wide range of antibacterial effects, mostly targeting Gram-negative bacteria, while its effectiveness against Gram-positive organisms is comparatively weaker. Gentamicin has significant efficacy against multidrug-resistant bacteria as well. Gentamicin is often used in conjunction with beta-lactam antibiotics to provide enhanced therapeutic efficacy via a synergistic effect, particularly in cases of Gram-positive and multidrug-resistant bacterial infections.
This study aims to evaluate the efficacy of administering gentamicin in combination with flucloxacillin as a pre-medication and for 48 hours after surgery in reducing the incidence of surgical site infections in patients undergoing cardiac surgeries, as compared to using a combination of ceftriaxone and flucloxacillin. Additionally, the study aimed to observes the therapeutic level of gentamicin required to achieve an effective concentration of the drug.
A prospective comparative study was conducted using an appropriate sample of 50 Iraqi patients undergone several types of cardiac surgeries.
A total of 50 patients (34 males and 16 females) between the ages of 18 and 75 were included in this study. These patients were admitted to the Surgical Department of the Iraqi Center for Heart Disease over a one-year period from January 2020 to January 2021. All patients underwent various types of cardiac surgery, such as coronary artery bypass graft (CABG), valve replacement, or device placement. The same surgical and anesthesia teams conducted the procedures.
A computerized randomization method was used to allocate patients into two groups in a randomized manner. Following the first interview, the patients were sequentially assigned numbers and then randomized into two groups via the online program Research Randomizer
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: Flucloxacillin and ceftriaxonePatients received flucloxacillin and ceftriaxone 60 minute before incision and then continued for 48 hours as follows: * Flucloxacillin 2g given before surgery then 1g * 4 for 48 hours after operation. * Ceftriaxone 1g given before surgery then 1g * 2 for 48 hours after operation. |
| Gentamicin | Experimental | Drug: Flucloxacillin and gentamicinPatients received flucloxacillin and gentamicin 60 minute before incision and then continued for 48 hours, as follows: * Flucloxacillin 2g given before surgery then 1g * 4 for 48 hours after operation. * Gentamicin 2mg/kg of ideal body weight given before surgery, then 80 mg *3 for 48 hours after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The research included individuals of both genders.
- Patients aged 18 and above.
- Patients had undergone any type of cardiac surgery.
Key exclusion criteria (4 listed)
- Patients having a prior diagnosis of organ failure.
- Patients already on antibiotics.
- Patients with elevated baseline renal function test before operation.
- Patients with contraindications to any of the prescribed medications were excluded from this study.
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 |
|---|---|---|
| Flucloxacillin and gentamicinThis intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI. | Drug | Gentamicin |
| Flucloxacillin and ceftriaxoneControl group | Drug | Control |
Primary outcome
White blood cells
Time frame: Up to 5 days post-surgery
White blood cells count (WBCs per microliter).
Hemoglobin level
Time frame: Up to 5 days post-surgery.
Hemoglobin concentration (g/dl).
Erythrocyte sedimentation rate
Time frame: Up to 5 days post-surgery.
Erythrocyte sedimentation rate (millimeters per hour).
Body temperature
Time frame: Up to 5 days post-surgery.
Body temperature measurement (Degrees Celsius °C).
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 12 Jun 2024.
- Results publication: PubMed 33859725Ackah JK, Neal L, Marshall NR, Panahi P, Lloyd C, Rogers LJ. Antimicrobial prophylaxis in adult cardiac surgery in the United Kingdom and Republic of Ireland. J Infect Prev. 2021 Mar;22(2):83-90. doi: 10.1177/1757177420971850. Epub 2020 Nov 24.
- Results publication: PubMed 23837413White RW, West R, Howard P, Sandoe J. Antimicrobial regime for cardiac surgery: the safety and effectiveness of short-course flucloxacillin (or teicoplanin) and gentamicin-based prophylaxis. J Card Surg. 2013 Sep;28(5):512-6. doi: 10.1111/jocs.12155. Epub 2013 Jul 9.
- Individual participant dataSharing planned: No
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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 Flucloxacillin and gentamicin and Flucloxacillin and ceftriaxone in people with Cardiac Infection, run by Al-Rasheed University College at 1 site in Iraq.
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 3 inclusion and 4 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 12 Jun 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 Iraq. 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?
White blood cells (time frame: Up to 5 days post-surgery). The study lists 4 primary outcomes in all. 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 NCT06454643, which also lists 2 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 12 Jun 2024.