Arrhythmia10-02725NCT01174251
The Effect of General Anesthesia on the Risk for Arrhythmia
An observational study of Arrhythmia, run by University of California, San Francisco at 1 site in United States.
Trial summary
Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form of ventricular arrhythmia with a characteristic twist of the QRS complex around the isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden cardiac death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A simple random sample will be chosen among all patients scheduled for general anesthesia in the UCSF affiliations Mt. Zion Hospital and Moffit/Long Hospital meeting all inclusion- and exclusion criteria.
Who may be able to join
- Male and female ASA I - III patients
- Age 18 years and older
- Scheduled for general anesthesia with a duration of at least 1 hour
Who cannot join
- Cardiac or thoracic surgery
- Planed postoperative ICU admission
- Non-English speaking
- Not in sinus rhythm
- Left and right bundle branch block
- Implanted pacemaker
- Mentally impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center (Moffitt/Long, Mt. Zion)
San Francisco, California, 94143
About this study
Official title: The Effect of General Anesthesia on the Risk for Arrhythmia -A Pilot Study
Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form of ventricular arrhythmia with a characteristic twist of the QRS complex around the isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden cardiac death. A predictor for the development of TdP is the length of the QT interval measured on an EKG recording. The QT interval is known to be prolonged by many medications used in a perioperative setting as well as by other conditions such as hypothermia and electrolyte imbalance. General anesthesia exposes most of the investigators patients to a combination of several of those medications and conditions and therefore might increase the risk for the development of QT prolongation. Moreover, patient related risk factors are well known and aggravate the individual risk for potential life threatening TdP events when exposed to QT prolonging medications perioperatively.
Previous research suggests that more than 20% of the patients might develop QT prolongations perioperatively and are consequently on an increased risk for TdP; yet, no study has systematically investigated the magnitude of the problem and associated risk factors.
The proposed pilot study is designed as a prospective observational cohort study to investigate the QT interval before, during and after general anesthesia. It aims to determine the incidence of perioperative QT prolongations. A customary long term EKG recording device will be connected to a random sample of patients undergoing general anesthesia. Using these continuous EKG tracings, the lengths of the QT interval will be analyzed during the perioperative period.
- Conditions
- Arrhythmia
- Keywords
- general anesthesia, electrocardiography, long QT syndrome, acquired
- Medical subject headings
- Arrhythmias, Cardiac, Long QT Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerstin Kolodzie, M.D., PhD, Principal investigator, Dept. of Anesthesia & Perioperative Care; University of California, San Francisco (UCSF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174251
- Sponsor's protocol ID
- H61125-34760-01
- Acronym
- 10-02725
- Status last verified
- Oct 2013
- First submitted
- 30 Jul 2010
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of General Anesthesia on the Risk for Arrhythmia -A Pilot Study
- ClinicalTrials.gov ID
- NCT01174251
- Acronym / sponsor ID
- 10-02725 / H61125-34760-01
- Conditions
- Arrhythmia
- Keywords
- general anesthesia, electrocardiography, long QT syndrome, acquired
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form of ventricular arrhythmia with a characteristic twist of the QRS complex around the isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden cardiac death. A predictor for the development of TdP is the length of the QT interval measured on an EKG recording. The QT interval is known to be prolonged by many medications used in a perioperative setting as well as by other conditions such as hypothermia and electrolyte imbalance. General anesthesia exposes most of the investigators patients to a combination of several of those medications and conditions and therefore might increase the risk for the development of QT prolongation. Moreover, patient related risk factors are well known and aggravate the individual risk for potential life threatening TdP events when exposed to QT prolonging medications perioperatively.
Previous research suggests that more than 20% of the patients might develop QT prolongations perioperatively and are consequently on an increased risk for TdP; yet, no study has systematically investigated the magnitude of the problem and associated risk factors.
The proposed pilot study is designed as a prospective observational cohort study to investigate the QT interval before, during and after general anesthesia. It aims to determine the incidence of perioperative QT prolongations. A customary long term EKG recording device will be connected to a random sample of patients undergoing general anesthesia. Using these continuous EKG tracings, the lengths of the QT interval will be analyzed during the perioperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A simple random sample will be chosen among all patients scheduled for general anesthesia in the UCSF affiliations Mt. Zion Hospital and Moffit/Long Hospital meeting all inclusion- and exclusion criteria.
Key inclusion criteria (3 listed)
- Male and female ASA I - III patients
- Age 18 years and older
- Scheduled for general anesthesia with a duration of at least 1 hour
Key exclusion criteria (7 listed)
- Cardiac or thoracic surgery
- Planed postoperative ICU admission
- Non-English speaking
- Not in sinus rhythm
- Left and right bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin Kolodzie, M.D., PhD principal investigator
Dept. of Anesthesia & Perioperative Care; University of California, San Francisco (UCSF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.