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NCT01669434 · ClinicalTrials.gov registry record · Phase 4
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
A Phase 4 study of Hypotension on Induction, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 4
- Development phase
- 291
- Enrollment target
- 1
- Study location
NCT01669434: Completed Phase 4 study of Hypotension on Induction, sponsored by University of Nebraska.
NCT01669434 is a Phase 4 study of Hypotension on Induction that has completed, run by University of Nebraska. The registered enrollment target is 291 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01669434, a Phase 4 study of Hypotension on Induction, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 291 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)
Conditions Studied
Interventions
- DRUG ACEI continuation
- DRUG ACEI omission
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2016-12-01 |
| Phase | Phase 4 |
What the finished NCT01669434 record still lists
NCT01669434 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Hypotension on Induction appearing as the primary indexed condition, and to 2 interventions - of which ACEI continuation is the first listed.
NCT01669434 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT01669434 about?
NCT01669434 is a clinical study titled "Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery". 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: P...
What is the current status of trial NCT01669434?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 291 participants. The study started on 2015-06-01. Estimated completion is 2016-12-01.
What conditions does trial NCT01669434 study?
This clinical trial studies the following conditions: Hypotension on Induction.
What interventions are being tested in trial NCT01669434?
The interventions under investigation include: ACEI continuation (DRUG), ACEI omission (DRUG).
Who is sponsoring clinical trial NCT01669434?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01669434 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01669434's enrollment target sits among peer trials
291 297th of 2000 higher than 1,704 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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