AsystoleNCT00527709
Hold Parameters on Likely Cardiovascular Depressant Medications
An observational study of Asystole and Bradycardia, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This pilot study is being pursued to observe whether certain medications are given to patients within a timeframe where their being given could play a part in a critical event in the management of the patient. There are general rules about when it would be appropriate for these types of medications not to be given. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asystole, Bradycardia, Hypotension
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2006
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Serial evaluation of the first 50 documented events of Code Blue or call to Rapid Response Team involving hypotension, bradycardia or asystole in the adult inpatient population events beginning January 1, 2006.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Hold Parameters on Likely Cardiovascular Depressant Medications (HOLD)
This pilot study is being pursued to observe whether certain medications are given to patients within a timeframe where their being given could play a part in a critical event in the management of the patient.
There are general rules about when it would be appropriate for these types of medications not to be given. However, it is not current standard practice for the criteria to be put in place without the expressed wishes of the ordering physician or their agent.
Research Question:
Can the administration of cardio-depressant medications be documented as a significant risk factor for hypotensive or bradycardic events?
- Conditions
- Asystole, Bradycardia, Hypotension
- Medical subject headings
- Heart Arrest, Bradycardia, Hypotension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startAug 2006
- Primary completionAug 2006
- Study completionAug 2006
Why it stopped: The study was a retrospective chart review and was mistakenly registered in ClinicalTrials.gov
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsystoleStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Tailor, MD, MBA, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527709
- Sponsor's protocol ID
- 06.01.025
- Status last verified
- Aug 2020
- First submitted
- 7 Sep 2007
- Last updated
- 5 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hold Parameters on Likely Cardiovascular Depressant Medications (HOLD)
- ClinicalTrials.gov ID
- NCT00527709
- Acronym / sponsor ID
- 06.01.025
- Conditions
- Asystole, Bradycardia, Hypotension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was a retrospective chart review and was mistakenly registered in ClinicalTrials.gov
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- Aug 2006 (actual)
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 11 Sep 2007 (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.
This pilot study is being pursued to observe whether certain medications are given to patients within a timeframe where their being given could play a part in a critical event in the management of the patient.
There are general rules about when it would be appropriate for these types of medications not to be given. However, it is not current standard practice for the criteria to be put in place without the expressed wishes of the ordering physician or their agent.
Research Question:
Can the administration of cardio-depressant medications be documented as a significant risk factor for hypotensive or bradycardic events?
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Serial evaluation of the first 50 documented events of Code Blue or call to Rapid Response Team involving hypotension, bradycardia or asystole in the adult inpatient population events beginning January 1, 2006.
Key exclusion criteria (0 listed)
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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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.
Amit Tailor, MD, MBA principal investigator
Hackensack Meridian Health
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 Asystole and Bradycardia, run by Hackensack Meridian Health 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 1 inclusion and 0 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: withdrawn, as of the sponsor's last update on 5 Aug 2020. 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 was withdrawn before enrolling participants, so there are no results.
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 5 Aug 2020.