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Continuation or stopping antihypertensives in patients undergoing non-cardiac surgery

The effect of continuation versus withholding angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers on mortality and major adverse cardiovascular events in hypertensive patients undergoing elective non-cardiac surgery: An open-label randomised controlled trial - ACE Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030199
Enrollment
2000
Registered
2021-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Stopping of antihypertensive medications (ACE inhibitors/ARB) before surgery.: The antihypertensive medications (ACE inhibitors/ Angiotensin II receptor blockers) will be with held befo

Sponsors

Dr Satyajeet Misra
Lead Sponsor
Dr Raj Sahajanandan
Collaborator
Dr Satyen Parida
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All hypertensive adult patients, 18-70 years, on chronic ACEI/ARB therapy (defined as treatment of more than 3 months or at least 14 days) and undergoing elective major non-cardiac surgery (defined as surgery lasting more than 2 hours and/or with an expected postoperative hospital stay of at least 3 days) will be included in this trial

Exclusion criteria

Exclusion criteria: Patients undergoing emergency surgeries within 48 hours, those with preoperative hyperkalemia (serum potassium > 5.5 mmol/L), patients with severe chronic renal insufficiency or those requiring renal replacement therapy, patients in shock (defined as need for vasoactive drugs to maintain blood pressures before surgery), patients taking ACEI/ARBs for LV dysfunction, and patients with uncontrolled hypertension will be excluded.

Design outcomes

Primary

MeasureTime frame
Composite incidence of 30-day all-cause mortality, major adverse cardiovascular events, and non-cardiovascular events (postoperative acute kidney injury, sepsis, respiratory failure requiring re-intubation, and unplanned ICU admissions due to any cause). Timepoint: 30 days after surgery.—

Secondary

MeasureTime frame
Cancellation of cases due to rebound hypertensionTimepoint: Preoperative;Duration of ICU stayTimepoint: Total duration of ICU stay;Duration of primary hospital stayTimepoint: Till discharge from primary hospital;Episodes of hypotensionTimepoint: Until 24 hours after surgery;Hospital free daysTimepoint: 30 days of surgery;Intraoperative angioneurotic edemaTimepoint: Intraoperative;Myocardial injuryTimepoint: 12/24 hours after surgery;Postoperative hyperkalaemia requiring interventionTimepoint: Till discharge from ICU and/or hospital—

Countries

India

Contacts

Public ContactDr Satyajeet Misra

All India Institute of Medical Sciences (AIIMS), Bhubaneswar

misrasatyajeet@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026