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临床试验/CTRI/2025/12/098280
CTRI/2025/12/098280尚未招募不适用

A Study on Potential Drug-Drug Interactions among Patients with Chronic Kidney Disease

NITTE (Deemed to be University),NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
217
试验地点
1
主要终点
The study will help to identify and assess the prevalence and severity of drug-drug interactions among chronic kidney disease patients.

研究概览

简要总结

INTRODUCTION:

Chronic Kidney Disease (CKD) is kidney damage or reduced function for over three months, affecting 700–850 million people worldwide. Comorbidities like hypertension, diabetes, heart disease, and dyslipidemia cause polypharmacy, raising the risk of pDDIs. These can lower efficacy, prolong hospitalization, increase costs, and cause mortality. Identifying factors aids safer prescribing and better outcomes.

OBJECTIVES OF THE STUDY:

To assess the potential drug-drug interactions among patients with chronic kidney disease and to study its severity.

METHODOLOGY:

A retrospective observational study will be conducted for a period of six months, from September 2025 to February 2026. The case sheets of inpatients who have undergone treatment for chronic kidney disease in the department of nephrology, from January 2023 to December 2024 will be reviewed from the Medical Records Department. The details pertaining to socio-demographic and clinical parameters as well as treatment related information will be collected in a well-designed data collection form. The potential drug-drug interactions will be identified using UpToDate software.

STATISTICAL ANALYSIS:

Statistical analysis will be done using SPSS 29.0. Qualitative data will be presented as frequency and percentage. Quantitative data will be presented as mean ± standard deviation. Factors associated with pDDIs will be analyzed using Chi-square/Fisher’s exact test. A p value <0.05 will be considered statistically significant.

OUTCOME MEASURES:

The study is expected to enable early identification and assessment of potential drug-drug interactions in CKD patients, allowing clinicians to implement necessary interventions to optimize therapy. As a result, it could help minimize adverse effects, reduce economic burden, and enhance both therapeutic effectiveness and the overall quality of prescribing.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients aged above 18 years, diagnosed with CKD and have received treatment.
  • Patient prescribed with more than one drug.

排除标准

  • Patients with incomplete medical records.
  • Critically ill patients.

结局指标

主要结局

The study will help to identify and assess the prevalence and severity of drug-drug interactions among chronic kidney disease patients.

时间窗: At baseline

次要结局

  • The Study will evaluate the association between the number of drugs prescribed and the risk of drug-drug interactions(One year)

研究者

发起方
NITTE (Deemed to be University),NGSM Institute of Pharmaceutical Sciences
申办方类型
Other [( Educational Institution )]
责任方
Principal Investigator
主要研究者

Leona Sweedal Cutinha

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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