Heart ArrestNCT01968148
Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest
An observational study of Heart Arrest and Cardiac Arrest, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Cardiac Arrest
- How many people
- 30 participants
- Where
- 2 sitesFinland
- Study dates
- Nov 2013to 30 Jul 2015
- 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: Successfully resuscitated patients treated by physician staffed mobile intensive care unit in Helsinki area.
Who may be able to join
- age ≥18 years
- witnessed cardiac arrest
- interval form emergency call to return of spontaneous circulation 10-45 minutes
Who cannot join
- severe pre-arrest disability leading to withdrawing treatment in prehospital phase
- no concent from next of kin
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki Emergency Medical Services
Helsinki
Helsinki Area Helicopter Emergency Medical Services
Vantaa
About this study
The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased secretion of insulin and glucose-like peptide 1 (GLP-1).
Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the samples.
Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.) survivors and non-survivors.
- Conditions
- Heart Arrest, Cardiac Arrest
- Keywords
- glucose, cardiac arrest, resuscitation, insulin, GLP-1
- Medical subject headings
- Heart Arrest, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of insulin
Measured: 60 minutes
Change in level of glucagon
Measured: 60 minutes
Secondary outcomes (4)
Blood cortisol level
Measured: 60 minutes after ROSC
Blood interleukin-6 level
Measured: 60 minutes after ROSC
Change in blood glucose level
Measured: 60 minutes
Change in level of GLP-1
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startNov 2013
- Primary completion30 Jul 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jouni Nurmi, MD, Helsinki University Central Hospital
- Investigators
- Jouni Nurmi, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968148
- Sponsor's protocol ID
- 357/13/03/12/2012 § 205
- Status last verified
- Mar 2018
- First submitted
- 19 Oct 2013
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01968148
- Acronym / sponsor ID
- 357/13/03/12/2012 § 205
- Conditions
- Heart Arrest, Cardiac Arrest
- Keywords
- glucose, cardiac arrest, resuscitation, insulin, GLP-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 23 Oct 2013 (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.
The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased secretion of insulin and glucose-like peptide 1 (GLP-1).
Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the samples.
Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.) survivors and non-survivors.
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
- Successfully resuscitated patients treated by physician staffed mobile intensive care unit in Helsinki area.
Key inclusion criteria (3 listed)
- age ≥18 years
- witnessed cardiac arrest
- interval form emergency call to return of spontaneous circulation 10-45 minutes
Key exclusion criteria (2 listed)
- severe pre-arrest disability leading to withdrawing treatment in prehospital phase
- no concent from next of kin
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
Change in level of insulin
Time frame: 60 minutes
Change in level of glucagon
Time frame: 60 minutes
4 secondary outcomes
Blood cortisol level
Time frame: 60 minutes after ROSC
Blood interleukin-6 level
Time frame: 60 minutes after ROSC
Change in blood glucose level
Time frame: 60 minutes
Change in level of GLP-1
Time frame: 60 minutes
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 13 Mar 2018.
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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.
Jouni Nurmi, MD, PhD principal investigator
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest and Cardiac Arrest, run by Helsinki University Central Hospital at 2 sites in Finland.
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 2 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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.
What does the primary outcome measure?
Change in level of insulin (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 13 Mar 2018.