Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Jason Shiffermiller, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01669434
First received: August 14, 2012
Last updated: August 16, 2012
Last verified: August 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Intraoperative Hypotension [ Time Frame: During anesthesia, an expected average of 3 hours. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Systolic blood pressure greater than 180 mmHg.


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (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
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

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669434

Contacts
Contact: Jason F Shiffermiller, MD, MPH 402-559-7299 jshiffermiller@unmc.edu
Contact: Chad Vokoun, MD 402-559-7299 cvokoun@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Sub-Investigator: Micah Beachy, DO         
Sub-Investigator: Joy Crossman, MD         
Sub-Investigator: Sheila Ellis, MD         
Sub-Investigator: Barbara Hurlbert, MD         
Sub-Investigator: James Sullivan, MD         
Sub-Investigator: Grant Turner         
Sub-Investigator: Andrew Vasey, MD         
Principal Investigator: Chad Vokoun, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jason F Shiffermiller, MD, MPH University of Nebraska
  More Information

Publications:

Responsible Party: Jason Shiffermiller, MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01669434     History of Changes
Other Study ID Numbers: 369-12-FB
Study First Received: August 14, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Perioperative Period

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

ClinicalTrials.gov processed this record on September 16, 2014