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The BETTER Surgery Pilot Trial

A prospective, multi-centre, randomised pilot trial of natriuretic peptide guided therapy to improve clinical outcomes for patients undergoing non-cardiac surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201609001780323
Enrollment
50
Registered
2016-09-13
Start date
2017-01-02
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative outcomes

Interventions

Natriuretic peptide directed changes to medical therapy
Standard of care

Sponsors

Clinical Research Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age ¿ 45 years of age. 2. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital. 3. With at least one of the following 4 criteria: a. History of ischaemic heart disease b. History of peripheral vascular disease c. History of stroke; OR d. Any 3 of the following 9 criteria:History of congestive cardiac failure, transient ischaemic attack, diabetes and currently on an oral hypoglycaemic agent or insulin, age¿70yrs, hypertension, serum creatinine >175 µmol/L (>2.0mg/dl), history of smoking within 2 years of surgery.

Exclusion criteria

Exclusion criteria: 1. Patient refusal to participate. 2. Where clinical opinion suggests that surgery cannot be postponed for at least 2 weeks to allow for clinical response to a change in medical therapy. 3. Percutaneous coronary intervention within the last two weeks.

Design outcomes

Primary

MeasureTime frame
Determine feasibility of recruiting patients undergoing noncardiac surgery to RCT of NP directed medical therapy prior to noncardiac surgery as compared to standard of care (defined as recruitment of 50 patients in one year).;Determine resources required to achieve recruitment, pre-operative randomization, and to conduct a full scale trial.;Assess compliance with trial protocol (defined as >90% complete follow up at 30 days postoperatively)

Secondary

MeasureTime frame
Incidence of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and myocardial injury after noncardiac surgery

Countries

South Africa

Contacts

Public ContactDelva Shamley
delva.shamley@uct.ac.za0743775287

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026