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Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669434
First Posted: August 21, 2012
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jason Shiffermiller, MD, University of Nebraska
  Purpose

Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of an intermediate risk surgery will experience more intraoperative hypotension than those who hold their chronic ACEI perioperatively.

Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of an intermediate risk surgery will experience better postoperative control of hypertension than those who hold their chronic ACEI perioperatively.

Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of an intermediate risk surgery will experience less acute renal failure than those who hold their chronic ACEI perioperatively.

Secondary research hypothesis #3: Patients with a preoperative systolic blood pressure less than 110 mmHg who are continued on their chronicACEI therapy perioperatively will have a significant decrease in blood pressure during anesthesia compared to those who have a preoperative systolic blood pressure greater than 110 who are continued on their chronic ACEI.

Secondary research hypothesis #4: Patients above the age of 64 who are continued on their chronic ACEI therapy perioperatively will have a significant decrease in blood pressure during anesthesia compared to those aged 64 or younger who are continued on their chronic ACEI.


Condition Intervention Phase
Hypertension Drug: Take ACE-I Drug: Hold ACE-I Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study

Further study details as provided by Jason Shiffermiller, MD, University of Nebraska:

Primary Outcome Measures:
  • Intraoperative Hypotension [ Time Frame: During anesthesia, an expected average of 3 hours. ]
    Systolic Blood Pressure under 60 mmHg or decreased 30% from pre-anesthesia reading


Secondary Outcome Measures:
  • Acute Renal Failure [ Time Frame: Arrival in 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

  • 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: Systolic Blood Pressure under 60 mmHg or decreased 30% from pre-anesthesia reading

  • 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: Systolic Blood Pressure under 60 mmHg or decreased 30% from pre-anesthesia reading

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


Enrollment: 291
Study Start Date: June 2015
Study Completion Date: December 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Take ACE-inhibitor
Patients in this arm will be randomized to take their chronic angiotensin converting enzyme inhibitor on the morning of surgery.
Drug: Take ACE-I
These chronic medications will be given on the morning of surgery.
Other Names:
  • quinapril
  • Accupril
  • perindopril
  • Aceon
  • ramipril
  • Altace
  • benazepril
  • Lotensin
  • captopril
  • Capoten
  • enalapril
  • Vasotec
  • fosinopril
  • Monopril
  • lisinopril
  • Prinivil
  • Zestril
  • trandolapril
  • Mavik
  • moexipril
  • Univasc
Hold ACE-I
Patients randomized to this arm will be told to hold their chronic angiotensin converting enzyme inhibitor on the morning of surgery.
Drug: Hold ACE-I
These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery.
Other Names:
  • quinapril
  • Accupril
  • perindopril
  • Aceon
  • ramipril
  • Altace
  • benazepril
  • Lotensin
  • captopril
  • Capoten
  • enalapril
  • Vasotec
  • fosinopril
  • Monopril
  • lisinopril
  • Prinivil
  • Zestril
  • trandolapril
  • Mavik
  • moexipril
  • Univasc

Detailed Description:
The purpose of this study is to determine if discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to intermediate risk surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the UNMC Pre-Anesthesia Screening (PAS) Clinic for an intermediate risk surgery who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either continue or hold their ACEI perioperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 60 mmHg or a decrease in systolic pressure greater than a 30%. 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
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 an intermediate risk 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
  Contacts and Locations
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
  More Information

Publications:
Mets, B. The renin-angiotensin system and ACE inhibitors in the peri-operative period. Baillieres Clin Anaesthesiol 11:581-604, 1997.
American College of Physicians. (n.d.). PIER. Retrieved from http://pier.acponline.org/physicians/diseases/d835/tables/d835-t1.html.

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 Submitted: August 14, 2012
First Posted: August 21, 2012
Last Update Posted: November 9, 2017
Last Verified: May 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:
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