Gentamicin in Cardiac Surgery

June 6, 2024 updated by: Al-Rasheed University College

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq, 10011
        • Baghdad Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The research included individuals of both genders.
  • Patients aged 18 and above.
  • Patients had undergone any type of cardiac surgery.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control

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.
Drug: Flucloxacillin and ceftriaxone
Control group
Experimental: Gentamicin

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.
Drug: Flucloxacillin and gentamicin
This intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White blood cells
Time Frame: Up to 5 days post-surgery
White blood cells count (WBCs per microliter).
Up to 5 days post-surgery
Hemoglobin level
Time Frame: Up to 5 days post-surgery.
Hemoglobin concentration (g/dl).
Up to 5 days post-surgery.
Erythrocyte sedimentation rate
Time Frame: Up to 5 days post-surgery.
Erythrocyte sedimentation rate (millimeters per hour).
Up to 5 days post-surgery.
Body temperature
Time Frame: Up to 5 days post-surgery.
Body temperature measurement (Degrees Celsius °C).
Up to 5 days post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Rasheed University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

May 26, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR200311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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