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Completed

NCT Number: NCT02320240

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

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.

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Key information

Conditions

Depression Acute Kidney Injury Behavior Behavioral Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lady Davis Institute for Medical Research, Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Duloxetine

Drug

Current exposure to Duloxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Venlafaxine

Drug

Current exposure to Venlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Desvenlafaxine

Drug

Current exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Citalopram

Drug

Current exposure to Citalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Escitalopram

Drug

Current exposure to Escitalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Fluoxetine

Drug

Current exposure to Fluoxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Fluvoxamine

Drug

Current exposure to Fluvoxamine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

paroxetine

Drug

Current exposure to Paroxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Sertraline

Drug

Current exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Primary outcomes

  1. Acute Kidney Injury (AKI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Canadian Network for Observational Drug Effect Studies, CNODES

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Drug Safety and Effectiveness Network, Canada

Registry information

Acronym: SNRI-AKI

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 19, 2014
Registry last updated
Mar 14, 2016

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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