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Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02320240
Acronym
SNRI-AKI
Enrollment
3255526
Registered
2014-12-19
Start date
2013-06-30
Completion date
2014-12-31
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Depression

Keywords

antidepressants, acute kidney injury, SNRI, renal failure, duloxetine, CNODES

Brief summary

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.

Detailed description

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.

Interventions

DRUGDuloxetine

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.

DRUGVenlafaxine

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.

DRUGDesvenlafaxine

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.

DRUGCitalopram

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.

DRUGEscitalopram

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.

DRUGFluoxetine

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.

DRUGFluvoxamine

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.

DRUGParoxetine

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.

DRUGSertraline

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.

Sponsors

Drug Safety and Effectiveness Network, Canada
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Canadian Network for Observational Drug Effect Studies, CNODES
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Acute Kidney Injury (AKI)2 yearsAKI 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026