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Therapeutic Hypothermia for Cardiac Arrest (ICECAP Trial)

N/A
Recruiting
Led By Robert Silbergleit
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Enrollment within 6 hours of initiation of cooling
Must not have
Hemodynamic instability
Presumed sepsis as etiology of arrest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days after return of spontaneous circulation
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults who've been in a coma after being resuscitated from a cardiac arrest outside of the hospital. They must be cooled to below 34 degrees Celsius within 4 hours of the event, with plans to maintain life support for at least 96 hours. It's not for those unstable after resuscitation, with pre-existing severe neurological issues or terminal illnesses, planned early life support withdrawal, sepsis-related arrests, or prisoners.
What is being tested?
The study is testing whether longer periods of induced hypothermia (cooling the body) can improve brain function outcomes in patients who have survived cardiac arrest but are comatose. The goal is to find out how long cooling should last to best protect the brain.
What are the potential side effects?
Therapeutic hypothermia may cause shivering, infection risk increase due to lowered body temperature, electrolyte imbalances like low potassium or magnesium levels which can affect heart rhythm and muscle function, and potential blood clotting issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I joined the study within 6 hours of starting cooling treatment.
Select...
I was in a coma after being resuscitated from a cardiac arrest outside of a hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood pressure and heart rate are stable.
Select...
My cardiac arrest was likely caused by sepsis.
Select...
I have a neurological condition that could affect study results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days after return of spontaneous circulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days after return of spontaneous circulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weighted Modified Rankin Scale (mRS)
Secondary study objectives
All Cause Mortality
Coagulopathies
Electrolyte abnormalities
+7 more

Side effects data

From 2014 Phase 3 trial • 295 Patients • NCT00878644
17%
Hypotension
15%
Hypoxic encephalopathy
14%
Hypokalemia
14%
Diabetes insipidus
13%
Anemia
13%
Hypertension
12%
Atelectasis
12%
Hyperglycemia
12%
Seizures
11%
Cerebral edema
10%
Seizure
10%
Anoxic brain damage
9%
Hypoglycemia
9%
Sputum culture positive
9%
Hypernatremia
8%
Hypocalcemia
8%
Pleural effusion
7%
Fever
6%
Hyponatremia
6%
Coagulopathy
6%
Oxygen saturation decreased
6%
Cardiac arrest
6%
Urine output decreased
5%
Pancreatitis
5%
Hyperkalemia
5%
Tachycardia
4%
Blood culture positive
4%
Hypomagnesemia
4%
Hypophosphatemia
4%
Pulmonary edema
4%
Leukocytosis
4%
Rhinovirus infection
4%
Thalamic syndrome
4%
Respiratory infection
4%
Bradycardia
4%
Shivering
4%
Urine culture positive
4%
Lactate dehydrogenase increased
4%
Pneumomediastinum
4%
Pneumothorax
4%
Agitation
4%
Brain herniation
4%
Potassium decreased
3%
Ischemia
3%
Urine output increased
3%
Tachypnea
3%
Hypoxic brain damage
3%
AST increased
3%
Low blood pressure
3%
Hypothermia
3%
Abnormal EEG
3%
Edema
3%
EEG abnormal
3%
Haemoglobin low
3%
Hyperchloremia
3%
Respiratory distress
3%
Skin breakdown
2%
Ventricular tachycardia
2%
Fluid overload
2%
Metabolic acidosis
2%
Anasarca
2%
Escherichia urinary tract infection
2%
Base excess decreased
2%
PO2 decreased
2%
Troponin increased
2%
Bacterial tracheitis
2%
Hypoxemia
2%
Retinal hemorrhage
2%
Diarrhea
2%
Emesis
2%
Pneumonia
2%
Sinusitis
2%
LDH increased
2%
Dysautonomia
2%
Status epilepticus
2%
Posturing
2%
Cardiac failure
2%
Acidosis
2%
Cerebral salt-wasting syndrome
1%
Anisocoria
1%
Pharyngeal edema
1%
Hyperthermia
1%
Asthma
1%
Hypercarbia
1%
Arterial blood pH decreased
1%
Loss of gag reflex
1%
Sinus tachycardia
1%
Adrenal insufficiency
1%
Ischemia cerebral
1%
Dilatation pupillary
1%
Premature ventricular contractions
1%
Acute renal failure
1%
Decreased hemoglobin
1%
Decreased ventricular afterload
1%
Hematocrit low
1%
Hemoglobin decreased
1%
INR decreased
1%
PT increased
1%
WBC increased
1%
Hypochloremia
1%
Hypoproteinemia
1%
Cerebral ischemia
1%
Clonus
1%
Coughing
1%
Diaphragmatic hernia
1%
Emphysema
1%
Unspecified disease of respiratory system
1%
Wheezing
1%
Poor peripheral perfusion
1%
Sepsis
1%
Septic shock
1%
Distended abdomen
1%
Edema of extremities
1%
Edema of lower extremities
1%
Extravasation
1%
Face oedema
1%
DIC
1%
Pneumatosis intestinalis
1%
Multi-organ failure
1%
Candida albicans infection
1%
Respiratory syncytial virus infection
1%
Tracheitis
1%
Myocardial depression
1%
Stools watery
1%
Swallowing disorder
1%
Multi-organ disorder
1%
Hepatomegaly
1%
Hyperbilirubinemia
1%
Liver failure
1%
Escherichia coli infection
1%
Gram-positive cocci infection
1%
Pseudomonas aeruginosa infection NOS
1%
Serous otitis media (glue ear)
1%
Staphylococcus aureus pneumonia
1%
Streptococcus viridans group infection
1%
Urinary tract infection bacterial
1%
Urine candida
1%
Bloody airway discharge
1%
Collapse of lung
1%
Renal injury
1%
Rib fracture
1%
Spinal epidural hematoma
1%
Tibia fracture
1%
APTT decreased
1%
Aspartate aminotransferase increased
1%
B-type natriuretic peptide
1%
BUN increased
1%
CPK increase
1%
CRP increased
1%
PCO2 increased
1%
Sodium low
1%
Transaminitis
1%
GI bleed
1%
Polyuria
1%
Renal function aggravated
1%
Aspiration
1%
Red man syndrome
1%
Hemodynamic instability
1%
Shock vascular
1%
Generalized edema
1%
Bacteria blood identified
1%
Encephalopathy
1%
Hematocrit decreased
1%
Cerebral infarction
1%
Respiratory insufficiency
1%
Hypertonia
1%
Oliguria
1%
Memory deficit
1%
Renal failure
1%
Hypercapnia
1%
Shock
1%
Jugular vein thrombosis
1%
Phlebitis
1%
DVT
1%
HIE
1%
CO2 total abnormal
1%
Glucose increased
1%
Glucose urine present
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%
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%
Pneumoperitoneum
1%
Saliva secretion excessive
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%
Septicemia
1%
Muscle spasms
1%
Acquired tracheobronchomalacia
1%
Apnea
1%
Aspiration pneumonia
1%
Clotting
1%
Cardiac failure aggravated
1%
Multi organ failure
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%
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%
Dilated pupils
1%
Fixed dilated pupils
1%
Gaze palsy
1%
Pupillary reaction slow
1%
Ascites
1%
Constipation
1%
Gastrointestinal bleeding
1%
Nausea
1%
Catheter site bleeding
1%
Gallbladder edema
1%
Clostridium difficile infection
1%
Haemophilus influenzae infection
1%
Lung infection
1%
Septicemia due to Escherichia coli (E. coli)
1%
Soft tissue infection
1%
Staphylococcal pneumonia
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%
ALT increased
1%
Amylase high
1%
Amylase increased
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%
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%
Metabolic alkalosis
1%
Autonomic dysfunction
1%
Autonomic instability
1%
Cerebral hematoma
1%
Increased intracranial pressure
1%
Myoclonic seizure NOS
1%
Myoclonus
1%
Shaking
1%
Tremor
1%
Anuria
1%
Interstitial lung disease
1%
Labored breathing
1%
Rash
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%
Band neutrophil count increased
1%
Lung injury
1%
Multiple organ failure
1%
Anoxic encephalopathy
1%
Intracranial hemorrhage
1%
Respiratory failure
1%
Respiratory failure aggravated
1%
Skin ulcer
1%
PVC's
1%
Retinopathy hemorrhagic
1%
Bacterial infection due to staphylococcus aureus
1%
Enterovirus infection
1%
Ventilator associated pneumonia
1%
Yeast infection
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%
Respiratory alkalosis
1%
Wheezing aggravated
1%
Blisters
1%
Diaper rash
1%
Redness
1%
Subcutaneous emphysema
1%
Ulcer skin
1%
Acute hypotension
1%
Venous thrombosis
1%
Platelet count increased
1%
Swelling of limb
1%
Lactate high
1%
Urine ketone body present
1%
Carbon monoxide poisoning
1%
Infusion site erythema
1%
Hypotonia
1%
Potassium increased
1%
Hypercholesterolemia
1%
Cerebral infarct
1%
Hypotensive
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 Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,159,959 Total Patients Enrolled
1 Trials studying Cardiac Arrest
89 Patients Enrolled for Cardiac Arrest
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
650,392 Total Patients Enrolled
1 Trials studying Cardiac Arrest
34 Patients Enrolled for Cardiac Arrest
University of MichiganLead Sponsor
1,856 Previous Clinical Trials
6,433,450 Total Patients Enrolled
3 Trials studying Cardiac Arrest
639 Patients Enrolled for Cardiac Arrest

Media Library

Therapeutic Hypothermia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04217551 — N/A
Cardiac Arrest Research Study Groups: 24 hour - non-shockable, 48 hours - non-shockable, 18 hours - shockable, 30 hours - shockable, 42 Hours - shockable, 6 hours - shockable, 24 hours - shockable, 60 hours - shockable, 60 hours - non-shockable, 6 hours - non shockable, 72 hours - non-shockable, 72 hours - shockable, 12 hours - shockable, 42 hours - non-shockable, 12 hours - non-shockable, 36 hours - non-shockable, 18 hours - non-shockable, 36 hours - shockable, 48 hours - shockable, 30 hours - non-shockable
Cardiac Arrest Clinical Trial 2023: Therapeutic Hypothermia Highlights & Side Effects. Trial Name: NCT04217551 — N/A
Therapeutic Hypothermia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04217551 — N/A
~798 spots leftby Jul 2028
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