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Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

Primary Purpose

Hypotension on Induction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ACEI continuation
ACEI omission
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension on Induction focused on measuring Perioperative Period

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ACEI continuation

ACEI omission

Arm Description

Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively

Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose.

Outcomes

Primary Outcome Measures

Number of Participants With Interoperative Hypotension
Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)

Secondary Outcome Measures

Acute Renal Failure
Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level
Low Blood Pressure Subgroup
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.
Older Age Subgroup
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
Postoperative Hypertension
Any systolic blood pressure greater than 180 mmHg.
Postoperative Hypotension
Any systolic blood pressure less than 90 mmHg

Full Information

First Posted
August 14, 2012
Last Updated
September 2, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01669434
Brief Title
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
Official Title
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension on Induction
Keywords
Perioperative Period

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACEI continuation
Arm Type
Experimental
Arm Description
Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively
Arm Title
ACEI omission
Arm Type
Experimental
Arm Description
Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose.
Intervention Type
Drug
Intervention Name(s)
ACEI continuation
Other Intervention Name(s)
quinapril, Accupril, perindopril, Aceon, ramipril, Altace, benazepril, Lotensin, captopril, Capoten, enalapril, Vasotec, fosinopril, Monopril, lisinopril, Prinivil, Zestril, trandolapril, Mavik, moexipril, Univasc
Intervention Description
These chronic medications will be taken without interruption preoperatively.
Intervention Type
Drug
Intervention Name(s)
ACEI omission
Other Intervention Name(s)
quinapril, Accupril, perindopril, Aceon, ramipril, Altace, benazepril, Lotensin, captopril, Capoten, enalapril, Vasotec, fosinopril, Monopril, lisinopril, Prinivil, Zestril, trandolapril, Mavik, moexipril, Univasc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Interoperative Hypotension
Description
Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)
Time Frame
During anesthesia, an expected average of 3 hours.
Secondary Outcome Measure Information:
Title
Acute Renal Failure
Description
Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level
Time Frame
Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.
Title
Low Blood Pressure Subgroup
Description
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.
Time Frame
During anesthesia, an expected average of 3 hours.
Title
Older Age Subgroup
Description
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
Time Frame
During anesthesia, an expected average of 3 hours.
Title
Postoperative Hypertension
Description
Any systolic blood pressure greater than 180 mmHg.
Time Frame
Arrival in PACU to hospital discharge, an expected average of 4 days.
Title
Postoperative Hypotension
Description
Any systolic blood pressure less than 90 mmHg
Time Frame
Arrival in PACU to hospital discharge, an expected average of 4 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason F Shiffermiller, MD, MPH
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

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