Neurological OutcomeNCT03112486
Out-of-hospital Cardiac Arrest (OHCA) Biomarkers
An observational study of Neurological Outcome and Cardiac Arrest, run by University of Florida at 1 site in United States.
Trial summary
Few early prognostic indicators are currently available for patients' families and clinicians following out of hospital cardiac arrest (OHCA), and blood biomarkers may be of prognostic value in these cases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurological Outcome, Cardiac Arrest, Out-Of-Hospital Cardiac Arrest
- What is being tested?
- blood draw
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 28 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include all adult patients (≥ 18 years of age) with non-traumatic out of hospital cardiac arrest. Exclusions will include patients with advanced directives precluding resuscitation, traumatic cardiac arrest, and irreversible signs of death (e.g. rigor mortis). A matched control population will include hemodynamically stable patients who present to the ED with chest pain that is not of cardiac etiology (non-traumatic chief complaints). Blood draws in this cohort will be collected as per protocol and will end upon the termination of medical care or as per protocol - whichever is of the least duration.
Who may be able to join
- >18 years old
- Study cohort:
- Non-traumatic out of hospital cardiac arrest
- Control cohort:
- Chest pain of non-cardiac etiology
Who cannot join
- Both cohorts:
- Females of child bearing age with positive pregnancy test
- Neurodegenerative disease or other neurological disorder (dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumours)
- History of neurosurgery within the last 30 days Acute brain injury within the last 30 days (ischemic/ haemorrhagic stroke, traumatic brain injury) Subject is anemic OR donated blood within the last 8 weeks OR has a hematological disorder that requires transfusions Subject has history of liver failure OR renal failure
- Study cohort:
- Advanced directives against resuscitation Traumatic cardiac arrest In hospital cardiac arrest Failure to attain ROSC + visible signs of death (livor mortis, rigor mortis)
- Control cohort:
- EKG changes: New ST-elevation consistent with myocardial infarction NSTEMI Hemodynamically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Neurological Outcome Following Out of Hospital Cardiac Arrest (OHCA) by Quantitative Measurement of Serial Serum Biomarkers of Brain Injury.
Few early prognostic indicators are currently available for patients' families and clinicians following out of hospital cardiac arrest (OHCA), and blood biomarkers may be of prognostic value in these cases. Brain tissue is highly dependent upon aerobic respiration, and oxygen deprivation result in irreversible neuronal cell injury. Peptides released into the blood by injured neuronal cells can be measured to estimate degree of injury, and potentially predict long term neurological outcome.
Read the detailed description
Aggressive treatment for patients with out-of-hospital cardiac arrest (OHCA) can result in return of spontaneous circulation (ROSC). However, prognosis for these patients remains poor, with low rates of survival to hospital admission and low rates of survival to hospital discharge. Furthermore, due to the exquisite sensitivity to hypoxic injury of neural tissue (dependent on aerobic respiration) relative to that of cardiac muscle, patients for whom ROSC can be obtained often suffer devastating neurological injury, with potential poor long-term neurological outcome. In some ischemic processes, for example, myocardial infarction, rapid measurement of cardiac biomarkers (e.g. Troponin isoform) is invaluable to current diagnosis and management. However, with regards to ischemic brain injury, there is currently no rapid, definitive diagnostic test to prognosticate outcome in OHCA. Biomarkers measurable in blood would have vital applications in prognosis and clinical research of neurological outcome in OHCA.
Other groups have studied the neurological predictive values of biomarkers after OHCA. A variety of proteins including S100B, neuron-specific enolase, and G-FAP, co-peptin, Tau, neurofilament light/ heavy chain, and secretoneurin have been proposed as potential biomarkers of neurological outcome at OHCA. Unfortunately, many of these have been shown to have several drawbacks. For example, some lack specificity due to being released during resuscitation (e.g., S100B is found extracerebrally in muscle, adipocytes, and chondrocytes, creating a confounding factor in CA patients receiving chest compressions). Others have lacked sufficient sensitivity in the prognosticating of neurological outcome (ref). Furthermore, there is a paucity of human studies in cardiac arrest on newer biomarkers that have been studied in other acute brain injury disease processes that could potentially serve as candidate biomarkers predicting neurological outcome at post cardiac arrest hypoxic brain injuries. Biomarkers such as UCH-L1, SBDP, and MBP have not been studied in a OHCA cohort.
The Investigator therefore propose a prospective, observational study in which the investigator will incorporate a minimally invasive and minimal risk measurement of blood biomarkers at time of ROSC. This would be done by drawing blood at ROSC (0-59mins), and additional blood draws at hours 6, 12, 18, 24, 48, 72, and on day 4, 5, and 6. The Investigator will then determine whether biomarker levels correlates with survival to hospital admission, survival to hospital discharge, and functional neurologic outcome at discharge and at 6 months. The Investigator intend to sample patients that present to the emergency department with non-CA chest pain in our study as well, which will allow us to draw stable inferences.
- Conditions
- Neurological Outcome, Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Brain Anoxia Ischemia, Hypoxia, Brain, Hypoxia-Ischemia, Brain
- Being tested
- blood draw
- Keywords
- out-of-hospital cardiac arrest, neurological outcome, prognostication, cerebral performance category, hypoxic-ischemic brain injury, biomarkers
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest, Hypoxia-Ischemia, Brain, Hypoxia, Brain, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawProcedure or surgery
Blood draws will be collected via venipuncture or IV at hours 0, 6, 12, 18, 24, 48, 72, 96, 120, 144 (10 draws total). Each draw would be approximately 20 mL of blood (but no less than 10 mL).
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Arrest cohort | adult patients (≥ 18 years of age) with non-traumatic out of hospital cardiac arrest Receives: Procedure: blood draw | |
| Control cohort | matched control population will include hemodynamically stable patients who present to the ED with chest pain that is not of cardiac etiology (non-traumatic chief complaints). Receives: Procedure: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Higher blood biomarker levels will correlate with reduced rate of survival to hospital admission, survival to hospital discharge, and 6-month survival.
Measured: 1 year
Secondary outcomes (2)
Functional neurological outcome at discharge
Higher blood biomarker levels will correlate with higher degree of neurological impairment as measured by Cerebral Performance Category.
Measured: 1 year
Functional neurological outcome at 6 months after discharge
Higher blood biomarker levels will correlate with higher degree of neurological impairment as measured by Cerebral Performance Category.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start26 May 2017
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Neurological OutcomeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph A Tyndall, MD, MPH, Principal investigator, Chairman Department Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112486
- Sponsor's protocol ID
- IRB201700133
- Status last verified
- May 2020
- First submitted
- 7 Apr 2017
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
PubMed 26673558Sasson C, Hegg AJ, Macy M, Park A, Kellermann A, McNally B; CARES Surveillance Group. Prehospital termination of resuscitation in cases of refractory out-of-hospital cardiac arrest. JAMA. 2008 Sep 24;300(12):1432-8. doi: 10.1001/jama.300.12.1432.
PubMed 18812534Chan PS, McNally B, Tang F, Kellermann A; CARES Surveillance Group. Recent trends in survival from out-of-hospital cardiac arrest in the United States. Circulation. 2014 Nov 18;130(21):1876-82. doi: 10.1161/CIRCULATIONAHA.114.009711.
PubMed 25399396Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. No abstract available.
PubMed 18948368Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. doi: 10.1007/s00134-004-2425-z. Epub 2004 Sep 9.
PubMed 15365608Moulaert VR, Verbunt JA, van Heugten CM, Wade DT. Cognitive impairments in survivors of out-of-hospital cardiac arrest: a systematic review. Resuscitation. 2009 Mar;80(3):297-305. doi: 10.1016/j.resuscitation.2008.10.034. Epub 2008 Dec 30.
PubMed 19117659Lim C, Verfaellie M, Schnyer D, Lafleche G, Alexander MP. Recovery, long-term cognitive outcome and quality of life following out-of-hospital cardiac arrest. J Rehabil Med. 2014 Jul;46(7):691-7. doi: 10.2340/16501977-1816.
PubMed 24849762Larsson IM, Wallin E, Rubertsson S, Kristofferzon ML. Health-related quality of life improves during the first six months after cardiac arrest and hypothermia treatment. Resuscitation. 2014 Feb;85(2):215-20. doi: 10.1016/j.resuscitation.2013.09.017. Epub 2013 Oct 2.
PubMed 24096198Pusswald G, Fertl E, Faltl M, Auff E. Neurological rehabilitation of severely disabled cardiac arrest survivors. Part II. Life situation of patients and families after treatment. Resuscitation. 2000 Nov;47(3):241-8. doi: 10.1016/s0300-9572(00)00240-9.
PubMed 11114453Sandroni C, Cavallaro F, Callaway CW, Sanna T, D'Arrigo S, Kuiper M, Della Marca G, Nolan JP. Predictors of poor neurological outcome in adult comatose survivors of cardiac arrest: a systematic review and meta-analysis. Part 1: patients not treated with therapeutic hypothermia. Resuscitation. 2013 Oct;84(10):1310-23. doi: 10.1016/j.resuscitation.2013.05.013. Epub 2013 Jun 27.
PubMed 23811182Sandroni C, Cavallaro F, Callaway CW, D'Arrigo S, Sanna T, Kuiper MA, Biancone M, Della Marca G, Farcomeni A, Nolan JP. Predictors of poor neurological outcome in adult comatose survivors of cardiac arrest: a systematic review and meta-analysis. Part 2: Patients treated with therapeutic hypothermia. Resuscitation. 2013 Oct;84(10):1324-38. doi: 10.1016/j.resuscitation.2013.06.020. Epub 2013 Jul 3.
PubMed 23831242Sandroni C, Geocadin RG. Neurological prognostication after cardiac arrest. Curr Opin Crit Care. 2015 Jun;21(3):209-14. doi: 10.1097/MCC.0000000000000202.
PubMed 25922894Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Grasner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Huei-Ming Ma M, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Eng Hock Ong M, Travers AH, Nolan JP; Utstein Collaborators. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: a statement for healthcare professionals from a task force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Circulation. 2015 Sep 29;132(13):1286-300. doi: 10.1161/CIR.0000000000000144. Epub 2014 Nov 11.
PubMed 25391522
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Neurological Outcome Following Out of Hospital Cardiac Arrest (OHCA) by Quantitative Measurement of Serial Serum Biomarkers of Brain Injury.
- ClinicalTrials.gov ID
- NCT03112486
- Acronym / sponsor ID
- IRB201700133
- Conditions
- Neurological Outcome, Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Brain Anoxia Ischemia, Hypoxia, Brain, Hypoxia-Ischemia, Brain
- Keywords
- out-of-hospital cardiac arrest, neurological outcome, prognostication, cerebral performance category, hypoxic-ischemic brain injury, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
Few early prognostic indicators are currently available for patients' families and clinicians following out of hospital cardiac arrest (OHCA), and blood biomarkers may be of prognostic value in these cases. Brain tissue is highly dependent upon aerobic respiration, and oxygen deprivation result in irreversible neuronal cell injury. Peptides released into the blood by injured neuronal cells can be measured to estimate degree of injury, and potentially predict long term neurological outcome.
Detailed description
Aggressive treatment for patients with out-of-hospital cardiac arrest (OHCA) can result in return of spontaneous circulation (ROSC). However, prognosis for these patients remains poor, with low rates of survival to hospital admission and low rates of survival to hospital discharge. Furthermore, due to the exquisite sensitivity to hypoxic injury of neural tissue (dependent on aerobic respiration) relative to that of cardiac muscle, patients for whom ROSC can be obtained often suffer devastating neurological injury, with potential poor long-term neurological outcome. In some ischemic processes, for example, myocardial infarction, rapid measurement of cardiac biomarkers (e.g. Troponin isoform) is invaluable to current diagnosis and management. However, with regards to ischemic brain injury, there is currently no rapid, definitive diagnostic test to prognosticate outcome in OHCA. Biomarkers measurable in blood would have vital applications in prognosis and clinical research of neurological outcome in OHCA.
Other groups have studied the neurological predictive values of biomarkers after OHCA. A variety of proteins including S100B, neuron-specific enolase, and G-FAP, co-peptin, Tau, neurofilament light/ heavy chain, and secretoneurin have been proposed as potential biomarkers of neurological outcome at OHCA. Unfortunately, many of these have been shown to have several drawbacks. For example, some lack specificity due to being released during resuscitation (e.g., S100B is found extracerebrally in muscle, adipocytes, and chondrocytes, creating a confounding factor in CA patients receiving chest compressions). Others have lacked sufficient sensitivity in the prognosticating of neurological outcome (ref). Furthermore, there is a paucity of human studies in cardiac arrest on newer biomarkers that have been studied in other acute brain injury disease processes that could potentially serve as candidate biomarkers predicting neurological outcome at post cardiac arrest hypoxic brain injuries. Biomarkers such as UCH-L1, SBDP, and MBP have not been studied in a OHCA cohort.
The Investigator therefore propose a prospective, observational study in which the investigator will incorporate a minimally invasive and minimal risk measurement of blood biomarkers at time of ROSC. This would be done by drawing blood at ROSC (0-59mins), and additional blood draws at hours 6, 12, 18, 24, 48, 72, and on day 4, 5, and 6. The Investigator will then determine whether biomarker levels correlates with survival to hospital admission, survival to hospital discharge, and functional neurologic outcome at discharge and at 6 months. The Investigator intend to sample patients that present to the emergency department with non-CA chest pain in our study as well, which will allow us to draw stable inferences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Arrest cohort | – | Procedure: blood drawadult patients (≥ 18 years of age) with non-traumatic out of hospital cardiac arrest |
| Control cohort | – | Procedure: blood drawmatched control population will include hemodynamically stable patients who present to the ED with chest pain that is not of cardiac etiology (non-traumatic chief complaints). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all adult patients (≥ 18 years of age) with non-traumatic out of hospital cardiac arrest. Exclusions will include patients with advanced directives precluding resuscitation, traumatic cardiac arrest, and irreversible signs of death (e.g. rigor mortis). A matched control population will include hemodynamically stable patients who present to the ED with chest pain that is not of cardiac etiology (non-traumatic chief complaints). Blood draws in this cohort will be collected as per protocol and will end upon the termination of medical care or as per protocol - whichever is of the least duration.
Key inclusion criteria (5 listed)
- >18 years old
- Non-traumatic out of hospital cardiac arrest
- Control cohort:
- Chest pain of non-cardiac etiology
Key exclusion criteria (8 listed)
- Females of child bearing age with positive pregnancy test
- Neurodegenerative disease or other neurological disorder (dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumours)
- History of neurosurgery within the last 30 days Acute brain injury within the last 30 days (ischemic/ haemorrhagic stroke, traumatic brain injury) Subject is anemic OR donated blood within the last 8 weeks OR has a hematological disorder that requires transfusions Subject has history of liver failure OR renal failure
- Advanced directives against resuscitation Traumatic cardiac arrest In hospital cardiac arrest Failure to attain ROSC + visible signs of death (livor mortis, rigor mortis)
- EKG changes: New ST-elevation consistent with myocardial infarction NSTEMI Hemodynamically unstable
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 |
|---|---|---|
| blood drawBlood draws will be collected via venipuncture or IV at hours 0, 6, 12, 18, 24, 48, 72, 96, 120, 144 (10 draws total). Each draw would be approximately 20 mL of blood (but no less than 10 mL). | Procedure or surgery | Cardiac Arrest cohort, Control cohort |
Primary outcome
In-hospital mortality
Time frame: 1 year
Higher blood biomarker levels will correlate with reduced rate of survival to hospital admission, survival to hospital discharge, and 6-month survival.
2 secondary outcomes
Functional neurological outcome at discharge
Time frame: 1 year
Functional neurological outcome at 6 months after discharge
Time frame: 1 year
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 May 2020.
- Background: PubMed 26673558Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
- Background: PubMed 18812534Sasson C, Hegg AJ, Macy M, Park A, Kellermann A, McNally B; CARES Surveillance Group. Prehospital termination of resuscitation in cases of refractory out-of-hospital cardiac arrest. JAMA. 2008 Sep 24;300(12):1432-8. doi: 10.1001/jama.300.12.1432.
- Background: PubMed 25399396Chan PS, McNally B, Tang F, Kellermann A; CARES Surveillance Group. Recent trends in survival from out-of-hospital cardiac arrest in the United States. Circulation. 2014 Nov 18;130(21):1876-82. doi: 10.1161/CIRCULATIONAHA.114.009711.
- Background: PubMed 18948368Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. No abstract available.
- Background: PubMed 15365608Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. doi: 10.1007/s00134-004-2425-z. Epub 2004 Sep 9.
- Background: PubMed 19117659Moulaert VR, Verbunt JA, van Heugten CM, Wade DT. Cognitive impairments in survivors of out-of-hospital cardiac arrest: a systematic review. Resuscitation. 2009 Mar;80(3):297-305. doi: 10.1016/j.resuscitation.2008.10.034. Epub 2008 Dec 30.
- Background: PubMed 24849762Lim C, Verfaellie M, Schnyer D, Lafleche G, Alexander MP. Recovery, long-term cognitive outcome and quality of life following out-of-hospital cardiac arrest. J Rehabil Med. 2014 Jul;46(7):691-7. doi: 10.2340/16501977-1816.
- Background: PubMed 24096198Larsson IM, Wallin E, Rubertsson S, Kristofferzon ML. Health-related quality of life improves during the first six months after cardiac arrest and hypothermia treatment. Resuscitation. 2014 Feb;85(2):215-20. doi: 10.1016/j.resuscitation.2013.09.017. Epub 2013 Oct 2.
- Background: PubMed 11114453Pusswald G, Fertl E, Faltl M, Auff E. Neurological rehabilitation of severely disabled cardiac arrest survivors. Part II. Life situation of patients and families after treatment. Resuscitation. 2000 Nov;47(3):241-8. doi: 10.1016/s0300-9572(00)00240-9.
- Background: PubMed 23811182Sandroni C, Cavallaro F, Callaway CW, Sanna T, D'Arrigo S, Kuiper M, Della Marca G, Nolan JP. Predictors of poor neurological outcome in adult comatose survivors of cardiac arrest: a systematic review and meta-analysis. Part 1: patients not treated with therapeutic hypothermia. Resuscitation. 2013 Oct;84(10):1310-23. doi: 10.1016/j.resuscitation.2013.05.013. Epub 2013 Jun 27.
- Background: PubMed 23831242Sandroni C, Cavallaro F, Callaway CW, D'Arrigo S, Sanna T, Kuiper MA, Biancone M, Della Marca G, Farcomeni A, Nolan JP. Predictors of poor neurological outcome in adult comatose survivors of cardiac arrest: a systematic review and meta-analysis. Part 2: Patients treated with therapeutic hypothermia. Resuscitation. 2013 Oct;84(10):1324-38. doi: 10.1016/j.resuscitation.2013.06.020. Epub 2013 Jul 3.
- Background: PubMed 25922894Sandroni C, Geocadin RG. Neurological prognostication after cardiac arrest. Curr Opin Crit Care. 2015 Jun;21(3):209-14. doi: 10.1097/MCC.0000000000000202.
- Individual participant dataSharing planned: Undecided
Related trials for Neurological Outcome
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
RecruitingObservational study
Correlation Between Clinical Neurological Biomarkers and Rehabilitation Outcome
Stroke
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
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.
Joseph A Tyndall, MD, MPH principal investigator
Chairman Department Emergency Medicine
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 Neurological Outcome and Cardiac Arrest, run by University of Florida 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 5 inclusion and 8 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 May 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 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?
In-hospital mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112486, which also lists 13 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 8 May 2020.