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Completed

NCT Number: NCT06454643

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baghdad Medical City

Baghdad, 10011, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flucloxacillin and gentamicin

Drug

This intervention aimed to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI.

Flucloxacillin and ceftriaxone

Drug

Control group

Primary outcomes

  1. White blood cells

    Time frame: Up to 5 days post-surgery

    White blood cells count (WBCs per microliter).

  2. Hemoglobin level

    Time frame: Up to 5 days post-surgery.

    Hemoglobin concentration (g/dl).

  3. Erythrocyte sedimentation rate

    Time frame: Up to 5 days post-surgery.

    Erythrocyte sedimentation rate (millimeters per hour).

  4. Body temperature

    Time frame: Up to 5 days post-surgery.

    Body temperature measurement (Degrees Celsius °C).

Sponsors and collaborators

Lead sponsor

Al-Rasheed University College

Other

Registry information

Official study title

The Pharmacological and Clinical Aspects of Using Gentamicin in Cardiac Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2024
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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