Cardiac Arrest
Conditions
Keywords
cardiac arrest, therapeutic hypothermia, microcirculation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEmicrocirculation by SDF and NIRS, in 33 and 36 degrees
at baseline, after 12 and 24 hours in both arms
Sponsors
Frisius Medisch Centrum
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* out-of-hospital cardiac arrest * \> 18 years * informed consent * ROSC (return of spontaneous circulation) \< 4 hours
Exclusion criteria
* recent maxillofacial surgery * participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular Flow Index (MFI) | baseline measurement | Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluid Balance After 24 Hours | 24 hours | — |
| Inotropes and Vasopressor Dose | baseline | — |
| RincStO2 | baseline | tissue oxygenation measured by Near Infrared Spectroscopy |
| Lactate | 24 hours | lactate levels in serum |
| SvO2 | 24 hours | (venous oxygen saturation) |
| Cardiac Index | 24 hours | Cardiac Index is cardiac output indexed for body weight |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| 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 | 13 |
| Total | 22 |
Baseline characteristics
| Characteristic | Normothermia, 36 Degrees | 33 Degrees, Therapeutic Hypothermia | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 12.4 | 68.9 years STANDARD_DEVIATION 9.3 | 66.6 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment Netherlands | 9 participants | 13 participants | 22 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 13 |
| serious Total, serious adverse events | 0 / 9 | 0 / 13 |
Outcome results
Primary
Microvascular Flow Index (MFI)
Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)
Time frame: baseline measurement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normothermia, 36 Degrees | Microvascular Flow Index (MFI) | 1.7 units on a scale |
| 33 Degrees, Therapeutic Hypothermia | Microvascular Flow Index (MFI) | 1.1 units on a scale |
Secondary
Cardiac Index
Cardiac Index is cardiac output indexed for body weight
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normothermia, 36 Degrees | Cardiac Index | 2.1 L/m2 | Standard Deviation 0.64 |
| 33 Degrees, Therapeutic Hypothermia | Cardiac Index | 1.9 L/m2 | Standard Deviation 0.73 |
Secondary
Fluid Balance After 24 Hours
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normothermia, 36 Degrees | Fluid Balance After 24 Hours | 1.79 liters | Standard Deviation 0.92 |
| 33 Degrees, Therapeutic Hypothermia | Fluid Balance After 24 Hours | 3.33 liters | Standard Deviation 1.18 |
Secondary
Inotropes and Vasopressor Dose
Time frame: baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normothermia, 36 Degrees | Inotropes and Vasopressor Dose | 0.00 mcg/kg/min |
| 33 Degrees, Therapeutic Hypothermia | Inotropes and Vasopressor Dose | 0.00 mcg/kg/min |
Secondary
Lactate
lactate levels in serum
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normothermia, 36 Degrees | Lactate | 1.71 mmol/l | Standard Deviation 0.48 |
| 33 Degrees, Therapeutic Hypothermia | Lactate | 2.78 mmol/l | Standard Deviation 1.1 |
Secondary
RincStO2
tissue oxygenation measured by Near Infrared Spectroscopy
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normothermia, 36 Degrees | RincStO2 | 44.6 percent saturation | Standard Deviation 15.8 |
| 33 Degrees, Therapeutic Hypothermia | RincStO2 | 58.9 percent saturation | Standard Deviation 13.5 |
Secondary
SvO2
(venous oxygen saturation)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normothermia, 36 Degrees | SvO2 | 61.2 percent saturation | Standard Deviation 13.6 |
| 33 Degrees, Therapeutic Hypothermia | SvO2 | 69.4 percent saturation | Standard Deviation 10.3 |