Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
Condition: Hypotension on Induction
MeSH terms: Hypotension
Intervention: ACEI continuation; ACEI omission
Intervention description: These chronic medications will be taken without interruption preoperatively.; Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.
Intervention MeSH terms: Ramipril; Enalapril; Enalaprilat; Lisinopril; Perindopril; Captopril; Benazepril; Quinapril; Trandolapril; Fosinopril; Moexipril; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 291.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Perioperative Period

Summary:

      Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and
      including the morning of a non-cardiac, non-vascular surgery will experience more
      intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

      Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and
      including the morning of a non-cardiac, non-vascular surgery will experience better
      postoperative control of hypertension than those who transiently hold their chronic ACEI
      preoperatively.

      Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and
      including the morning of a non-cardiac, non-vascular surgery will experience less acute renal
      failure than those who transiently hold their chronic ACEI preoperatively.

      Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic
      blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and
      including the morning of a non-cardiac, non-vascular surgery will experience more
      intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

      Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who
      continue their chronic ACEI therapy up to and including the morning of a non-cardiac,
      non-vascular surgery will experience more intraoperative hypotension than those who
      transiently hold their chronic ACEI preoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Referred to the University of Nebraska Medical Center Pre-Anesthesia Screening Clinic
             for preoperative evaluation.

          -  Above referral must be in anticipation of a non-cardiac, non-vascular surgery.

          -  Must have been on ACE-Inhibitor therapy for at least six weeks.

        Exclusion Criteria:

          -  Hypotension (systolic blood pressure < 90 or diastolic blood pressure <60) at the time
             of preoperative evaluation

          -  Uncontrolled Hypertension (systolic blood pressure > 150 or diastolic blood pressure >
             95) at the time of preoperative evaluation

          -  Surgery during which vasopressor use is anticipated (carotid endarterectomy, major
             abdominal operations, orthopedic oncology)

          -  Surgery for pathology related to vasoactive substances (carcinoid, pheochromocytoma)

          -  Left Ventricular ejection fraction less than 40%

          -  Clinical evidence of decompensated heart failure at the time of preoperative
             evaluation

          -  End-stage renal disease

          -  Organ transplant surgeries