Antihypertensive Medications and the Risk of Sepsis | NCT02248896

Studies
Antihypertensive Medications and the Risk of Sepsis

NCT02248896

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 25, 2014Estimated

Enrollment

1,129,062Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Telmisartan
Other angiotensin-receptor blockers (ARBs)
Angiotensin-converting enzyme inhibitors (ACEIs)
Other major antihypertensive medication classes

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Not provided

First Submitted Date

Sep 24, 2014

First Submission Date that Met QC Criteria

Sep 24, 2014

First Posted Date

Sep 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,129,062Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypertensive patients		Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data	Drug: Telmisartan Drug: Other angiotensin-receptor blockers (ARBs) Drug: Angiotensin-converting enzyme inhibitors (ACEIs) Drug: Other major antihypertensive medication classes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan	Drug		Hypertensive patients
Other angiotensin-receptor blockers (ARBs)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurence of sepsis, including severe sepsis	Severe sepsis defined as cases that develop renal failure or die within 30 days	Up to 9 years and 5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of, or treatment for hypertension

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077333	Telmisartan
D000806	Angiotensin-Converting Enzyme Inhibitors

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided