The Impact of Preoperative Statin Therapy and and Its Intensity on Postoperative and Mortality and Morbidity

NCT07575737 | Completed

• 1 other identifier: 2024-01664-01
• Study Type: observational
• Target: 70,000
• Locations: 1 country
• Sites: 2

Brief Summary

Statins are among the most widely prescribed drugs worldwide, and their benefits in cardiovascular risk reduction are well established. Beyond lipid lowering, statins exert pleiotropic effects - including anti-inflammatory, antioxidant, and endothelial-stabilizing properties - that have generated longstanding interest in their potential to mitigate perioperative complications. Major surgery provokes a systemic inflammatory response, endothelial activation, and hemodynamic stress that may precipitate myocardial injury, organ dysfunction, and death, particularly in patients with pre-existing cardiovascular disease. We therefore examined the association between preoperative statin therapy and its intensity with postoperative all-cause mortality and days at home alive after major non-cardiac surgery in a large, contemporary, dual center-based cohort.

Conditions

Perioperative Care

Outcome Measures

Primary Outcomes (1)

• 30- and 365-day mortality

  Death within the time frames described

  30 and 365 days respectively

Secondary Outcomes (1)

• DAH30 (Days At Home alive at 30 days) and DAH365 (Days At Home alive at 365 days)

  30 and 365 days after index surgery,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery

You may qualify if:

• Adults aged ≥ 18 years at the time of surgery
• Elective (non-emergency) surgical procedure
• Non-cardiac surgery (all surgical specialties except cardiac surgery)

You may not qualify if:

• Obstetric surgery
• Transplant surgery
• Planned day-case surgery (procedures with intended same-day discharge)
• Anesthetic monitoring episodes not involving a surgical procedure (e.g., anesthetic support for central venous catheter insertion)
• Urological brachytherapy
• Stereotactic radiosurgery (Gamma Knife or equivalent)
• Repeat or subsequent surgical procedures during the study period - only the index (chronologically first eligible) procedure per patient is included in the analysis

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Karolinska University Hospital Huddinge

Stockholm, Sweden

Location

Karolinska University Hospital Solna

Stockholm, Sweden

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: May 14, 2024
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

SE (2)