Study Stopped
too slow recruitment; lack of funding
The Effect of Sevoflurane Versus Isoflurane on Vasopressor Need
ESIVAN
1 other identifier
interventional
10
1 country
1
Brief Summary
Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedApril 21, 2015
April 1, 2015
6 months
June 12, 2009
April 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total amount of the vasopressor phenylephrine that is needed to maintain blood pressure above 60 mmHg during 10 minutes of Cardiopulmonary bypass.
10 minutes
Secondary Outcomes (1)
Mean blood pressure throughout the 10 minute periods, the need for a stronger vasopressor (norepinephrine) and the inability to keep mean blood pressure below 75 mmHg at MAC 0.6.
10 minutes
Study Arms (2)
Sevoflurane
ACTIVE COMPARATORAdministration of the volatile anesthetic Sevoflurane.
Isoflurane
ACTIVE COMPARATORAdministration of the volatile anesthetic Isoflurane.
Interventions
Patients will be randomized to a 10 minute treatment with isoflurane, followed by a wash-out period, followed by a 10 minute treatment with sevoflurane, or the other way round.
Eligibility Criteria
You may qualify if:
- competent adult patients (18 years or older)undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass.
You may not qualify if:
- Patients undergoing valve surgery or combined surgical procedures (e.g. coronary artery bypass grafting in combination with valve reconstruction.
- uncontrolled hypertension
- a poor left ventricular function
- renal failure
- a body mass index of \> 25
- history of cerebrovascular accident, transient ischemic accident or carotid artery stenosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
University Medical Center
Utrecht, Utrecht, 3984 CX, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
C.J. Kalkman, MD, PhD
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 17, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
April 21, 2015
Record last verified: 2015-04