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Antihypertensive Medications and the Risk of Sepsis

NCT ID: NCT02248896

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1129062 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Brief Summary

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The primary objective of this study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other ARBs and with the other major antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other three major antihypertensive classes and with untreated hypertension, is associated with an increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan compared with other ARBs, ACEIs and other major antihypertensive classes is associated with an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and death

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Detailed Description

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Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hypertensive patients

Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data

Telmisartan

Intervention Type DRUG

Other angiotensin-receptor blockers (ARBs)

Intervention Type DRUG

Angiotensin-converting enzyme inhibitors (ACEIs)

Intervention Type DRUG

Other major antihypertensive medication classes

Intervention Type DRUG

e.g. beta-blockers, calcium channel blockers (CCBs), diuretics

Interventions

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Telmisartan

Intervention Type DRUG

Other angiotensin-receptor blockers (ARBs)

Intervention Type DRUG

Angiotensin-converting enzyme inhibitors (ACEIs)

Intervention Type DRUG

Other major antihypertensive medication classes

e.g. beta-blockers, calcium channel blockers (CCBs), diuretics

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Patients, 18 years or older, with at least two-year follow-up in United Kingdom's general practice research database (GPRD), who had a diagnosis of or treatment for hypertension

Exclusion Criteria

\- Sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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502.590

Identifier Type: -

Identifier Source: org_study_id

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