Trial Outcomes & Findings for Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest (NCT NCT01850485)

NCT ID: NCT01850485

Last Updated: 2015-06-25

Results Overview

Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)

• Recruitment status: COMPLETED
• Target enrollment: 22 participants
• Primary outcome timeframe: baseline measurement
• Results posted on: 2015-06-25

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	9	13
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest

Baseline characteristics by cohort

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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	Total n=22 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 12.4 • n=93 Participants	68.9 years STANDARD_DEVIATION 9.3 • n=4 Participants	66.6 years STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	12 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment Netherlands	9 participants n=93 Participants	13 participants n=4 Participants	22 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline measurement

Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)

Outcome measures

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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
Microvascular Flow Index (MFI)	1.7 units on a scale Interval 0.7 to 2.4	1.1 units on a scale Interval 0.4 to 1.9

SECONDARY outcome

Timeframe: baseline

tissue oxygenation measured by Near Infrared Spectroscopy

Outcome measures

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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
RincStO2	44.6 percent saturation Standard Deviation 15.8	58.9 percent saturation Standard Deviation 13.5

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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
Fluid Balance After 24 Hours	1.79 liters Standard Deviation 0.92	3.33 liters Standard Deviation 1.18

SECONDARY outcome

Timeframe: baseline

Outcome measures

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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
Inotropes and Vasopressor Dose	0.00 mcg/kg/min Interval 0.0 to 1.9	0.00 mcg/kg/min Interval 0.0 to 4.89

SECONDARY outcome

Timeframe: 24 hours

Cardiac Index is cardiac output indexed for body weight

Outcome measures

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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
Cardiac Index	2.1 L/m2 Standard Deviation 0.64	1.9 L/m2 Standard Deviation 0.73

SECONDARY outcome

Timeframe: 24 hours

lactate levels in serum

Outcome measures

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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
Lactate	1.71 mmol/l Standard Deviation 0.48	2.78 mmol/l Standard Deviation 1.1

SECONDARY outcome

Timeframe: 24 hours

(venous oxygen saturation)

Outcome measures

Measure	Normothermia, 36 Degrees n=9 Participants 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	33 Degrees, Therapeutic Hypothermia n=13 Participants 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
SvO2	61.2 percent saturation Standard Deviation 13.6	69.4 percent saturation Standard Deviation 10.3

Adverse Events

Normothermia, 36 Degrees

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

33 Degrees, Therapeutic Hypothermia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matty Koopmans, MSc

Medical Center Leeuwarden

Phone: 0031582866738

Email: matty.koopmans@znb.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place