Effect of the “Triple whammy” in hospitalization due to acute kidney injury: a case-control study nested in a cohort

Study identification

• EU PAS number:
  EUPAS35832
• Study ID:
  42755
• Official title and acronym:
  Effect of the “Triple whammy” in hospitalization due to acute kidney injury: a case-control study nested in a cohort
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Background: the term “triple whammy” refers to the simultaneous use of diuretics, renin-angiotensin-aldosterone system inhibitors (angiotensin-converting enzime inhibitors (ACEI) and angiotensin II receptor blockers (ARBs)) and nonsteroidal anti-inflammatory drugs (NSAIDs). The use of this combination has been associated with an increased risk of kidney injury (AKI). Main objective: to analyze the incidence of hospitalization due to AKI associated to the exposure to the “triple whammy” combination versus non-exposure to that combination. Secondary objectives: 1) To assess the risk of hospitalization due to AKI with the combination "triple whammy" that includes metamizole versus the combination that includes an NSAID different to metamizole, 2) To evaluate the risk of hospitalization due to AKI based on the time window from the index date and according to its duration, 3) To determine the risk of requiring renal replacement therapy and mortality associated to the "triple whammy" combination.
• Study status:
  Planned

Research institutions and networks

Institutions

Navarre Health Service

Study timelines

Date when funding contract was signed

Planned: 18/11/2019

Study start date

Planned: 03/05/2021

Data analysis start date

Planned: 01/10/2021

Date of interim report, if expected

Planned: 31/12/2021

Date of final study report

Planned: 31/03/2021

Sources of funding

Other

More details on funding

Government of Navarre

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable