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Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

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ClinicalTrials.gov Identifier: NCT01669434
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jason Shiffermiller, MD, University of Nebraska

Brief 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.


Condition or disease Intervention/treatment Phase
Hypotension on Induction Drug: ACEI continuation Drug: ACEI omission Phase 4

Detailed Description:
The purpose of this study is to determine if transient discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 80 mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery and the remainder of hospitalization. Renal function will be assessed with creatinine measurements in the PAS clinic and on the first postoperative day. No follow-up is planned beyond discharge from the hospital.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study
Study Start Date : June 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACEI continuation
Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively
Drug: ACEI continuation
These chronic medications will be taken without interruption preoperatively.
Other Names:
  • quinapril
  • Accupril
  • perindopril
  • Aceon
  • ramipril
  • Altace
  • benazepril
  • Lotensin
  • captopril
  • Capoten
  • enalapril
  • Vasotec
  • fosinopril
  • Monopril
  • lisinopril
  • Prinivil
  • Zestril
  • trandolapril
  • Mavik
  • moexipril
  • Univasc

Experimental: ACEI omission
Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose.
Drug: ACEI omission
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.
Other Names:
  • quinapril
  • Accupril
  • perindopril
  • Aceon
  • ramipril
  • Altace
  • benazepril
  • Lotensin
  • captopril
  • Capoten
  • enalapril
  • Vasotec
  • fosinopril
  • Monopril
  • lisinopril
  • Prinivil
  • Zestril
  • trandolapril
  • Mavik
  • moexipril
  • Univasc




Primary Outcome Measures :
  1. Number of Participants With Interoperative Hypotension [ Time Frame: During anesthesia, an expected average of 3 hours. ]
    Systolic Blood Pressure under 80 mmHg


Secondary Outcome Measures :
  1. Acute Renal Failure [ Time Frame: Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days. ]
    Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level

  2. Low Blood Pressure Subgroup [ Time Frame: During anesthesia, an expected average of 3 hours. ]
    Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg.

  3. Older Age Subgroup [ Time Frame: During anesthesia, an expected average of 3 hours. ]
    Only patients above the age of 64 will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg

  4. Postoperative Hypertension [ Time Frame: Arrival in PACU to hospital discharge, an expected average of 4 days. ]
    Any systolic blood pressure greater than 180 mmHg.

  5. Postoperative Hypotension [ Time Frame: Arrival in PACU to hospital discharge, an expected average of 4 days. ]
    Any systolic blood pressure less than 90 mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669434


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jason F Shiffermiller, MD, MPH University of Nebraska

Publications:
Rate of all-listed procedures for discharges from short-stay hospitals, by procedure category and age: United States, 2010. 2010.

Responsible Party: Jason Shiffermiller, MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01669434     History of Changes
Other Study ID Numbers: 369-12-FB
First Posted: August 21, 2012    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jason Shiffermiller, MD, University of Nebraska:
Perioperative Period

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Enalapril
Enalaprilat
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Benazepril
Perindopril
Captopril
Quinapril
Trandolapril
Fosinopril
Moexipril
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs