跳至主要内容
临床试验/NCT06454643
NCT06454643已完成不适用

The Pharmacological and Clinical Aspects of Using Gentamicin in Cardiac Surgery

Al-Rasheed University College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
White blood cells

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Flucloxacillin and ceftriaxone (Drug)

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.

干预措施: Flucloxacillin and gentamicin (Drug)

结局指标

主要结局

White blood cells

时间窗: Up to 5 days post-surgery

White blood cells count (WBCs per microliter).

Hemoglobin level

时间窗: Up to 5 days post-surgery.

Hemoglobin concentration (g/dl).

Erythrocyte sedimentation rate

时间窗: Up to 5 days post-surgery.

Erythrocyte sedimentation rate (millimeters per hour).

Body temperature

时间窗: Up to 5 days post-surgery.

Body temperature measurement (Degrees Celsius °C).

次要结局

未报告次要终点

研究者

发起方
Al-Rasheed University College
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Gentamicin in Cardiac Surgery | 临床试验