Hypoxic Brain InjurySjO2NCT00870610
Jugular Venous Oxygen Saturation During Therapeutic Hypothermia After Cardiac Arrest
An observational study of Hypoxic Brain Injury and Hypothermia, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The purpose of this study is to understand what happens to cerebral metabolism during therapeutic hypothermia for hypoxic brain injury following cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypoxic Brain Injury, Hypothermia
- What is being tested?
- retrograde jugular venous cannulation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Dec 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who are in coma after cardiac arrest, admitted to the Intensive Care Unit of a University Teaching Hospital and undergoing therapeutic hypothermia
Who may be able to join
- Adult patients in coma after cardiac arrest undergoing therapeutic hypothermia
Who cannot join
- Age < 18
- Pregnancy
- Traumatic brain injury
- Contraindications to cannulation as severe coagulopathy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Intensive Care Unit-Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Milan, 20122
About this study
Official title: Cerebral Metabolism During Therapeutic Hypothermia for Cardiac Arrest
The purpose of this study is to understand what happens to cerebral metabolism during therapeutic hypothermia for hypoxic brain injury following cardiac arrest.
Read the detailed description
Latest international guidelines recommend the use of therapeutic hypothermia in patients who have had cardiac arrest and remain in coma after return of spontaneous circulation. This is recommended essentially to limit the cerebral injury caused by cardiac arrest and possibly amplified upon reperfusion. At times, although a spontaneous circulation has returned, cerebral oxygenation may remain inadequate due to inadequate perfusion pressure, and hypothermia, by reducing cardiac output and cerebral blood flow could actually aggravate this phenomenon. The rewarming period is thought to be at greatest risk of inadequate oxygenation for the increase in metabolic demand. With this study we aim to understand what happens to cerebral oxygenation and metabolism during therapeutic hypothermia for cardiac arrest through cerebrovenous oxygen saturation monitoring and in particular, to see whether through this type of monitoring we could recognize otherwise unnoticed periods of inadequate cerebral oxygenation.
- Conditions
- Hypoxic Brain Injury, Hypothermia
- Being tested
- retrograde jugular venous cannulation
- Keywords
- jugular venous oxygen saturation, hypothermia
- Medical subject headings
- Hypoxia, Brain, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde jugular venous cannulationProcedure or surgery
Also called SjO2, cerebrovenous oxygen saturation
Retrograde cannulation of jugular vein and intermittent sampling of venous blood from cerebral circulation before, during and after hypothermia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypoxic Brain InjuryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, Policlinico Hospital
- Investigators
- Davide Chiumello, MD, Principal investigator, Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870610
- Sponsor's protocol ID
- 2010
- Acronym
- SjO2
- Status last verified
- Apr 2015
- First submitted
- 10 Mar 2009
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.
PubMed 12847056Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
PubMed 11856794Macmillan CS, Andrews PJ. Cerebrovenous oxygen saturation monitoring: practical considerations and clinical relevance. Intensive Care Med. 2000 Aug;26(8):1028-36. doi: 10.1007/s001340051315.
PubMed 11030158
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Metabolism During Therapeutic Hypothermia for Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00870610
- Acronym / sponsor ID
- SjO2 / 2010
- Conditions
- Hypoxic Brain Injury, Hypothermia
- Keywords
- jugular venous oxygen saturation, hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Mar 2009 (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 purpose of this study is to understand what happens to cerebral metabolism during therapeutic hypothermia for hypoxic brain injury following cardiac arrest.
Detailed description
Latest international guidelines recommend the use of therapeutic hypothermia in patients who have had cardiac arrest and remain in coma after return of spontaneous circulation. This is recommended essentially to limit the cerebral injury caused by cardiac arrest and possibly amplified upon reperfusion. At times, although a spontaneous circulation has returned, cerebral oxygenation may remain inadequate due to inadequate perfusion pressure, and hypothermia, by reducing cardiac output and cerebral blood flow could actually aggravate this phenomenon. The rewarming period is thought to be at greatest risk of inadequate oxygenation for the increase in metabolic demand. With this study we aim to understand what happens to cerebral oxygenation and metabolism during therapeutic hypothermia for cardiac arrest through cerebrovenous oxygen saturation monitoring and in particular, to see whether through this type of monitoring we could recognize otherwise unnoticed periods of inadequate cerebral oxygenation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are in coma after cardiac arrest, admitted to the Intensive Care Unit of a University Teaching Hospital and undergoing therapeutic hypothermia
Key inclusion criteria (1 listed)
- Adult patients in coma after cardiac arrest undergoing therapeutic hypothermia
Key exclusion criteria (4 listed)
- Age < 18
- Pregnancy
- Traumatic brain injury
- Contraindications to cannulation as severe coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrograde jugular venous cannulationAlso: SjO2, cerebrovenous oxygen saturationRetrograde cannulation of jugular vein and intermittent sampling of venous blood from cerebral circulation before, during and after hypothermia. | Procedure or surgery | – |
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 28 Apr 2015.
- Background: PubMed 12847056Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.
- Background: PubMed 11856794Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
- Background: PubMed 11030158Macmillan CS, Andrews PJ. Cerebrovenous oxygen saturation monitoring: practical considerations and clinical relevance. Intensive Care Med. 2000 Aug;26(8):1028-36. doi: 10.1007/s001340051315.
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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.
Davide Chiumello, MD principal investigator
Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
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 Hypoxic Brain Injury and Hypothermia, run by Policlinico Hospital at 1 site in Italy.
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 4 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 28 Apr 2015. 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 Italy. 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?
On the ClinicalTrials.gov record for NCT00870610, which also lists 3 linked publications.
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 28 Apr 2015.