Other
Therapeutic Hypothermia for Cardiac Arrest
UPMC Harrisburg, Harrisburg, PA
Targeting 3 different conditionsTherapeutic HypothermiaN/ARecruitingLed by Robert SilbergleitResearch Sponsored by University of MichiganEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cooled to <34 deg C with 240 minutes of cardiac arrest
Coma after resuscitation from out of hospital cardiac arrest
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up90 days after return of spontaneous circulation
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing if longer periods of induced hypothermia are better for patients' neurological outcomes after cardiac arrest, in order to identify the optimal duration of induced hypothermia.
Eligible Conditions
- Cardiac Arrest
- Hypoxic-Ischemic Brain Injury
- Hypothermia
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You were in a coma after being resuscitated from cardiac arrest that occurred outside of a hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days after return of spontaneous circulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days after return of spontaneous circulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weighted Modified Rankin Scale (mRS)
Secondary outcome measures
All Cause Mortality
Coagulopathies
Electrolyte abnormalities
+7 moreSide effects data
From 2014 Phase 3 trial • 295 Patients • NCT0087864417%
Hypotension
15%
Hypoxic encephalopathy
14%
Diabetes insipidus
14%
Hypokalemia
13%
Anemia
13%
Hypertension
12%
Hyperglycemia
12%
Seizures
12%
Atelectasis
11%
Cerebral edema
10%
Seizure
10%
Anoxic brain damage
9%
Sputum culture positive
9%
Hypernatremia
9%
Hypoglycemia
8%
Hypocalcemia
8%
Pleural effusion
7%
Fever
6%
Oxygen saturation decreased
6%
Coagulopathy
6%
Cardiac arrest
6%
Hyponatremia
6%
Urine output decreased
5%
Pancreatitis
5%
Hyperkalemia
5%
Tachycardia
4%
Leukocytosis
4%
Rhinovirus infection
4%
Thalamic syndrome
4%
Pulmonary edema
4%
Respiratory infection
4%
Bradycardia
4%
Shivering
4%
Urine culture positive
4%
Lactate dehydrogenase increased
4%
Hypomagnesemia
4%
Hypophosphatemia
4%
Pneumomediastinum
4%
Pneumothorax
4%
Blood culture positive
4%
Agitation
4%
Brain herniation
4%
Potassium decreased
3%
Hypothermia
3%
Abnormal EEG
3%
Ischemia
3%
Edema
3%
AST increased
3%
EEG abnormal
3%
Haemoglobin low
3%
Hyperchloremia
3%
Tachypnea
3%
Hypoxic brain damage
3%
Respiratory distress
3%
Skin breakdown
3%
Urine output increased
3%
Low blood pressure
2%
Fluid overload
2%
PO2 decreased
2%
Anasarca
2%
Troponin increased
2%
Bacterial tracheitis
2%
Hypoxemia
2%
Ventricular tachycardia
2%
Retinal hemorrhage
2%
Diarrhea
2%
Emesis
2%
Pneumonia
2%
Sinusitis
2%
Base excess decreased
2%
LDH increased
2%
Dysautonomia
2%
Status epilepticus
2%
Posturing
2%
Cardiac failure
2%
Escherichia urinary tract infection
2%
Acidosis
2%
Cerebral salt-wasting syndrome
2%
Metabolic acidosis
1%
HIE
1%
Shock vascular
1%
CO2 total abnormal
1%
CPK increase
1%
Glucose increased
1%
Glucose urine present
1%
Asthma
1%
Atrial tachycardia
1%
Heart rate increased
1%
Bowel ischemia
1%
Gastroesophageal reflux
1%
ARDS
1%
Staphylococcal infection
1%
Chloride low
1%
Creatinine increased
1%
Leukopenia
1%
Hypoalbuminemia
1%
Anisocoria
1%
Blood osmolarity increased
1%
Blood pH abnormal
1%
Blood phosphorus increased
1%
IIIrd nerve palsy
1%
Ischemic stroke
1%
Gastrointestinal mucosal sloughing
1%
Gum erosion
1%
Pancreatitis aggravated
1%
Pneumatosis intestinalis
1%
Pneumoperitoneum
1%
Saliva secretion excessive
1%
Stools watery
1%
Vomiting
1%
Ionized calcium decreased
1%
Swelling of legs
1%
Acute liver injury
1%
Bilateral pneumonia
1%
Hypoxia
1%
Catheter site infection
1%
Central line infection
1%
Pulmonary edema recurrent
1%
Pulmonary hypertension
1%
Pulmonary vascular disorder
1%
Respiratory acidosis
1%
Respiratory tract infection bacterial
1%
Septic shock
1%
Septicemia
1%
Muscle spasms
1%
Memory deficit
1%
Acquired tracheobronchomalacia
1%
Apnea
1%
Aspiration
1%
Aspiration pneumonia
1%
Clotting
1%
Cardiac failure aggravated
1%
Multi organ failure
1%
Multi-organ disorder
1%
Pyrexia
1%
Klebsiella pneumonia
1%
Klebsiella pneumoniae infection
1%
Infection pseudomonas aeruginosa
1%
Neurological status deterioration
1%
UTI
1%
Urinary tract infection
1%
Pulmonary hemorrhage
1%
DVT
1%
Hemodynamic instability
1%
DIC
1%
Disseminated intravascular coagulation
1%
Neutropenia
1%
Thrombocytopenia
1%
Subdural hemorrhage
1%
Bundle branch block
1%
Cardiomegaly
1%
Fibrosis myocardial
1%
Junctional rhythm
1%
Left ventricular dysfunction
1%
Left ventricular systolic dysfunction
1%
Myocardial depression
1%
Adrenal insufficiency
1%
Dilatation pupillary
1%
Dilated pupils
1%
Fixed dilated pupils
1%
Gaze palsy
1%
Pupillary reaction slow
1%
Ascites
1%
Constipation
1%
Distended abdomen
1%
GI bleed
1%
Gastrointestinal bleeding
1%
Nausea
1%
Swallowing disorder
1%
Catheter site bleeding
1%
Edema of extremities
1%
Edema of lower extremities
1%
Generalized edema
1%
CRP increased
1%
Gallbladder edema
1%
Clostridium difficile infection
1%
Haemophilus influenzae infection
1%
Decreased hemoglobin
1%
Decreased ventricular afterload
1%
Lung infection
1%
Pseudomonas aeruginosa infection NOS
1%
Respiratory syncytial virus infection
1%
Septicemia due to Escherichia coli (E. coli)
1%
Serous otitis media (glue ear)
1%
Soft tissue infection
1%
Staphylococcal pneumonia
1%
Staphylococcus aureus pneumonia
1%
Tracheitis
1%
Urinary tract infection bacterial
1%
Urine candida
1%
Bloody airway discharge
1%
Collapse of lung
1%
Femur fracture
1%
Fracture of upper end or unspecified part of radius and ulna, closed
1%
Fractured cervical spine
1%
Humerus fracture
1%
Iatrogenic pneumothorax
1%
Ligament injury
1%
Renal injury
1%
Rib fracture
1%
Spinal epidural hematoma
1%
Tibia fracture
1%
ALT increased
1%
APTT decreased
1%
Amylase high
1%
Amylase increased
1%
Arterial blood pH decreased
1%
Aspartate aminotransferase increased
1%
B-type natriuretic peptide
1%
BUN increased
1%
Bacteria blood identified
1%
Blood bicarbonate decreased
1%
Blood bicarbonate low
1%
Blood pressure increased
1%
Creatine phosphokinase increased
1%
Drug level above therapeutic
1%
Elevated liver enzymes
1%
Fecal occult blood
1%
Function pulmonary decreased
1%
Gastric pH decreased
1%
Glucose decreased
1%
Glucose high
1%
Hematocrit decreased
1%
Hematocrit low
1%
Hemoglobin decreased
1%
INR decreased
1%
INR increased
1%
Increased blood pressure
1%
Lactate increased
1%
Lipase increased
1%
Magnesium decreased
1%
Methicillin-resistant Staphylococcus aureus test positive
1%
Neurological examination abnormal
1%
PCO2 abnormal
1%
PTT prolonged
1%
Phosphorus low
1%
Sodium increased
1%
Alkalosis
1%
Hyperammonemia
1%
Hyperamylasemia
1%
Hyperlipasemia
1%
Hypermagnesemia
1%
Hyperphosphatemia
1%
Hypochloremia
1%
Hypoproteinemia
1%
Metabolic alkalosis
1%
Autonomic dysfunction
1%
Autonomic instability
1%
Cerebral hematoma
1%
Encephalopathy
1%
Hypertonia
1%
Increased intracranial pressure
1%
Myoclonic seizure NOS
1%
Myoclonus
1%
Shaking
1%
Tremor
1%
Acute renal failure
1%
Anuria
1%
Oliguria
1%
Polyuria
1%
Renal failure
1%
Renal function aggravated
1%
Coughing
1%
Diaphragmatic hernia
1%
Hypercapnia
1%
Hypercarbia
1%
Interstitial lung disease
1%
Labored breathing
1%
Pharyngeal edema
1%
Unspecified disease of respiratory system
1%
Wheezing
1%
Rash
1%
Red man syndrome
1%
Aortic thrombosis
1%
Blood pressure fluctuation
1%
Clot blood
1%
Coldness of lower extremities
1%
DVT of legs
1%
Deep vein thrombosis leg
1%
Thrombosis leg
1%
Sodium low
1%
Band neutrophil count increased
1%
Lung injury
1%
Multi-organ failure
1%
Multiple organ failure
1%
Candida albicans infection
1%
Sepsis
1%
Anoxic encephalopathy
1%
Intracranial hemorrhage
1%
Ischemia cerebral
1%
Loss of gag reflex
1%
Respiratory failure
1%
Respiratory failure aggravated
1%
Skin ulcer
1%
PVC's
1%
Premature ventricular contractions
1%
Sinus tachycardia
1%
Retinopathy hemorrhagic
1%
Extravasation
1%
Face oedema
1%
Hepatomegaly
1%
Hyperbilirubinemia
1%
Liver failure
1%
Bacterial infection due to staphylococcus aureus
1%
Enterovirus infection
1%
Escherichia coli infection
1%
Gram-positive cocci infection
1%
Streptococcus viridans group infection
1%
Ventilator associated pneumonia
1%
Yeast infection
1%
PT increased
1%
Acidosis metabolic
1%
Feeding difficulties and mismanagement
1%
Azotemia
1%
Urinary retention
1%
Breathing abnormally shallow
1%
Bronchial wall thickening
1%
Chronic respiratory failure
1%
Emphysema
1%
Respiratory alkalosis
1%
Respiratory insufficiency
1%
Wheezing aggravated
1%
Blisters
1%
Diaper rash
1%
Redness
1%
Subcutaneous emphysema
1%
Ulcer skin
1%
Acute hypotension
1%
Venous thrombosis
1%
Hyperthermia
1%
PCO2 increased
1%
Phlebitis
1%
Swelling of limb
1%
Lactate high
1%
Transaminitis
1%
Urine ketone body present
1%
Carbon monoxide poisoning
1%
WBC increased
1%
Infusion site erythema
1%
Hypotonia
1%
Platelet count increased
1%
Potassium increased
1%
Hypercholesterolemia
1%
Cerebral infarct
1%
Cerebral infarction
1%
Cerebral ischemia
1%
Clonus
1%
Hypotensive
1%
Jugular vein thrombosis
1%
Poor peripheral perfusion
1%
Shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Therapeutic Normothermia
Therapeutic Hypothermia
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
20Treatment groups
Experimental Treatment
Group I: 72 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group II: 72 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group III: 60 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group IV: 60 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group V: 6 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
Group VI: 6 hours - non shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.
Group VII: 48 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group VIII: 48 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group IX: 42 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group X: 42 Hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group XI: 36 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group XII: 36 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group XIII: 30 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group XIV: 30 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group XV: 24 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group XVI: 24 hour - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.
Group XVII: 18 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
Group XVIII: 18 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.
Group XIX: 12 hours - shockableExperimental Treatment1 Intervention
Participants with shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
Group XX: 12 hours - non-shockableExperimental Treatment1 Intervention
Participants with non-shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Hypothermia
2013
Completed Phase 3
~990
Find a site
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,297 Previous Clinical Trials
459,058 Total Patients Enrolled
1 Trials studying Cardiac Arrest
34 Patients Enrolled for Cardiac Arrest
National Institutes of Health (NIH)NIH
2,595 Previous Clinical Trials
6,795,031 Total Patients Enrolled
1 Trials studying Cardiac Arrest
89 Patients Enrolled for Cardiac Arrest
University of MichiganLead Sponsor
1,702 Previous Clinical Trials
6,561,976 Total Patients Enrolled
3 Trials studying Cardiac Arrest
639 Patients Enrolled for Cardiac Arrest
Medical University of South CarolinaOTHER
886 Previous Clinical Trials
5,361,277 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,149 Previous Clinical Trials
14,807,556 Total Patients Enrolled
3 Trials studying Cardiac Arrest
1,322 Patients Enrolled for Cardiac Arrest
Robert SilbergleitPrincipal Investigator
University of MichiganRomer GeocadinPrincipal Investigator
Johns Hopkins UniversityWilliam MeurerPrincipal Investigator
University of MichiganMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the population size of this research endeavor?
"Affirmative. According to the information provided on clinicaltrials.gov, this research endeavour is still searching for participants. It was initially posted in May of 2020 and amended most recently in November 2022; it seeks 1800 individuals from 67 different locations."
Answered by AI
In what proportion of healthcare facilities is this experiment being conducted?
"This research initiative is actively recruiting patients from OSU Wexner Medical Center in Columbus, Ohio, Mercy St. Vincent Medical Center in Toledo, California and Ronald Regan UCLA Medical Center Los Angeles, Georgia alongside 67 other sites."
Answered by AI
Are there vacancies for enrolment in this experiment?
"As per the information hosted on clinicaltrials.gov, this medical study is currently taking in participants. The trial was inaugurated on May 18th 2020 and recently updated November 22nd 2022."
Answered by AI