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临床试验/NCT02320240
NCT02320240已完成不适用

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Canadian Network for Observational Drug Effect Studies, CNODES1 个研究点 分布在 1 个国家目标入组 3,255,526 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,255,526
试验地点
1
主要终点
Acute Kidney Injury (AKI)

研究概览

简要总结

The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of depression.

详细描述

We plan to conduct retrospective population-based cohort studies within eight administrative databases from Canada, the United States, and the United Kingdom. Within each cohort, a nested case-control analysis will be performed to estimate incidence rate ratios (RR) of AKI associated with SNRIs compared to SSRIs using conditional logistic regression, with adjustment for high-dimensional propensity scores at baseline. The overall effect across sites will then be estimated using meta-analytic methods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.

排除标准

  • They were <12 years old at the time of cohort entry.
  • They had less than 1 year of information in the database prior to the date of cohort entry.
  • They had a prescription of an SNRI or SSRI in the year before the date of cohort entry.
  • They had a prescription for both an SNRI and an SSRI on the day of cohort entry.
  • They had a history of chronic kidney disease (including kidney transplantation and dialysis) or AKI in the year preceding cohort entry.
  • The subject was previously included in the cohort.

研究组 & 干预措施

SNRI Exposure Group

Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.

干预措施: Duloxetine (Drug)

SNRI Exposure Group

Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.

干预措施: Venlafaxine (Drug)

SNRI Exposure Group

Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.

干预措施: Desvenlafaxine (Drug)

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

干预措施: Citalopram (Drug)

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

干预措施: Escitalopram (Drug)

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

干预措施: Fluoxetine (Drug)

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

干预措施: Fluvoxamine (Drug)

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

干预措施: Paroxetine (Drug)

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

干预措施: Sertraline (Drug)

结局指标

主要结局

Acute Kidney Injury (AKI)

时间窗: 2 years

AKI will be defined as patients hospitalized with one of the following diagnosis codes for AKI in any of the listed diagnoses: ICD-9-CM codes 584, 584.5, 584.6, 584.7, 584.8, or 584.9; ICD-10 N17, N17.0, N17.1, N17.2, N17.8, or N17.9.

次要结局

未报告次要终点

研究者

发起方
Canadian Network for Observational Drug Effect Studies, CNODES
申办方类型
Other
责任方
Sponsor

研究点 (1)

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