Phase 2 N=100 Randomized Quadruple-blind Treatment

Physiologic Effects of Steroids in Cardiac Arrest

Inhospital Cardiac Arrest

Bottom Line

View on ClinicalTrials.gov: NCT02790788 ↗

Enrolled (actual)

100

Serious AEs

98.0%

Results posted

Nov 2019

Primary outcome: Primary: Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible). — 78.4; 75.1 mmHg — p=0.44

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Methylprednisolone; hydrocortisone (Drug); Saline Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Athens
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).	83.9; 78.9	0.17
PRIMARY Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).	67.4; 56.8	0.043 sig
PRIMARY Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).	83.9; 78.9	0.17
PRIMARY Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).	67.4; 56.8	0.043 sig
PRIMARY Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.	85.2; 84.7	0.90
PRIMARY Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.	72.5; 70.4	0.33
PRIMARY Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.	85.2; 84.7	0.90
PRIMARY Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.	72.5; 70.4	0.33
PRIMARY Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.	85.2; 84.7	0.90
PRIMARY Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.	72.5; 70.4	0.33
SECONDARY Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.	23.1; 22.8; 12.1; 13.0; 23.1; 18.5	0.92
SECONDARY Left and Right Ventricular Ejection Fraction (%) by Echocardiography.	42.3; 45.9; 41.7; 42.7; 45; 50	0.32
SECONDARY Eccentricity Index by Echocardiography.	1.2; 1.3; 1.3; 1.3; 1.2; 1.3	0.41
SECONDARY Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	5.8; 5.6	0.65
SECONDARY Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	5.8; 5.6	0.65
SECONDARY Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	5.8; 5.6	0.65
SECONDARY Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.	5.8; 5.6	0.65
SECONDARY Core Body Temperature in Degrees Celcius.	36.5; 35.6; 36.3; 36.6; 36.0; 36.5	0.41
SECONDARY Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.	4.0; 3.3; 4.2; 3.5; 4.3; 3.4	0.42
SECONDARY Organ Failure-free Days.	0; 0	0.84
SECONDARY Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).	2.19; 2.22; 1.97; 2.03; 2.07; 2.03	0.86
SECONDARY Survival to Hospital Discharge With Favorable Functional Outcome.	2; 5	0.45
SECONDARY Steroid-associated Complications.	0; 0; 0; 0; 0; 0	0.68

Summary

Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors plan to conduct a prospective, randomized, placebo controlled evaluation of stress-dose steroids efficacy with repect to early postresuscitation hemodynamics, heart function, brain perfusion, and inflammatory response in vasopressor-requiring cardiac arrest. Patients will also be followed for organ dysfunction, potential, steroid-associated complications, and functional outcome at hospital discharge.

Eligibility Criteria

Inclusion Criteria

Adult in-patients with ROSC [for at least 20 min] after cardiac arrest due to

Ventricular fibrillation/pulseless tachycardia not responsive to three direct current countershocks, or
Asystole, or
Pulseless electrical activity.

Exclusion Criteria

Age <18 years
Terminal illness (i.e. life expectancy <6 weeks e.g. due to metastatic cancer, or Sequential Organ Dysfunction Assessment score of 15 or more, or new septic complication in the presence of immunosuppression) or do-not- resuscitate status
Cardiac arrest due to exsanguination (e.g. ruptured aortic aneurysm)
Cardiac arrest before hospital admission
Pre-arrest treatment with intravenous corticosteroids
Any history of an allergic reaction
Transmural myocardial infarction
Previous enrollment in or exclusion from the current study.
Confirmation of return of spontaneous circulation before study-drug administration, corresponding to "premature randomization" [reference 18] will also result in patient exclusion due to absence of vasopressor-requiring cardiac arrest.

Additional Exclusion Criteria According to the Protocol Amendment approved on January 24, 2017: Any deviation from the hospital's standard resuscitative procedure.

Pre-arrest diagnosis of an "active" peptic ulcer. Projected ICU admission time of more than 48 hours in case of a concurrent, special public health circumstance (e.g. severe flu outbreak) that may abruptly increase the demand for intensive care.

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Data sourced from ClinicalTrials.gov (NCT02790788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.