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The hypothesis is: In patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°C) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated with 36°C.
The purpose of this study is to investigate the (sublingual) microcirculation in patients after an out of hospital cardiac arrest (OHCA). The microcirculation is measured in this study by Sublingual Side Stream Darkfield (SDF) Imaging and Near InfraRed Spectroscopy (NIRS) at admission and after 12 and 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normothermia, 36 degrees | microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees, difference is temperature, in this group 36 |
| |
| 33 degrees, therapeutic hypothermia | microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees, difference is temperature, in this group 33 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microcirculation by SDF and NIRS, in 33 and 36 degrees | Device | at baseline, after 12 and 24 hours in both arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microvascular Flow Index (MFI) | Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow) | baseline measurement |
| Measure | Description | Time Frame |
|---|---|---|
| RincStO2 | tissue oxygenation measured by Near Infrared Spectroscopy | baseline |
| Fluid Balance After 24 Hours | 24 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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patients after out of hospital cardiac arrest
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| Name | Affiliation | Role |
|---|---|---|
| Matty Koopmans, RN | medical center leeuwarden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25449350 | Derived | Koopmans M, Kuiper MA, Endeman H, Veenstra G, Vellinga NA, de Vos R, Boerma EC. Microcirculatory perfusion and vascular reactivity are altered in post cardiac arrest patients, irrespective of target temperature management to 33 degrees C vs 36 degrees C. Resuscitation. 2015 Jan;86:14-8. doi: 10.1016/j.resuscitation.2014.09.025. Epub 2014 Oct 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normothermia, 36 Degrees | microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms |
| FG001 | 33 Degrees, Therapeutic Hypothermia | microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normothermia, 36 Degrees | microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms |
| BG001 | 33 Degrees, Therapeutic Hypothermia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Microvascular Flow Index (MFI) | Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow) | Posted | Median | Inter-Quartile Range | units on a scale | baseline measurement |
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normothermia, 36 Degrees | microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms |
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Relative small sample size Large inter individual variability in microvascular reactivity
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matty Koopmans, MSc | Medical Center Leeuwarden | 0031582866738 | matty.koopmans@znb.nl |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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|
| Inotropes and Vasopressor Dose |
| baseline |
| Cardiac Index | Cardiac Index is cardiac output indexed for body weight | 24 hours |
| Lactate | lactate levels in serum | 24 hours |
| SvO2 | (venous oxygen saturation) | 24 hours |
microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | RincStO2 | tissue oxygenation measured by Near Infrared Spectroscopy | Posted | Mean | Standard Deviation | percent saturation | baseline |
|
|
|
| Secondary | Fluid Balance After 24 Hours | Posted | Mean | Standard Deviation | liters | 24 hours |
|
|
|
| Secondary | Inotropes and Vasopressor Dose | Posted | Median | Inter-Quartile Range | mcg/kg/min | baseline |
|
|
|
| Secondary | Cardiac Index | Cardiac Index is cardiac output indexed for body weight | Posted | Mean | Standard Deviation | L/m2 | 24 hours |
|
|
|
| Secondary | Lactate | lactate levels in serum | Posted | Mean | Standard Deviation | mmol/l | 24 hours |
|
|
|
| Secondary | SvO2 | (venous oxygen saturation) | Posted | Mean | Standard Deviation | percent saturation | 24 hours |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 33 Degrees, Therapeutic Hypothermia | microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms | 0 | 13 | 0 | 13 |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |