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OpenTrials
Completed

NCT Number: NCT02248896

Antihypertensive Medications and the Risk of Sepsis

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Telmisartan

Drug

Other angiotensin-receptor blockers (ARBs)

Drug

Angiotensin-converting enzyme inhibitors (ACEIs)

Drug

Other major antihypertensive medication classes

Drug

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

Primary outcomes

  1. Occurence of sepsis, including severe sepsis

    Time frame: Up to 9 years and 5 months

    Severe sepsis defined as cases that develop renal failure or die within 30 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

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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