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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days after return of spontaneous circulation
Awards & highlights
ICECAP Trial 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.Check my eligibility
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.See study design
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.
ICECAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ICECAP Trial 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%
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%
Pleural effusion
8%
Hypocalcemia
7%
Fever
6%
Coagulopathy
6%
Hyponatremia
6%
Oxygen saturation decreased
6%
Cardiac arrest
6%
Urine output decreased
5%
Pancreatitis
5%
Hyperkalemia
5%
Tachycardia
4%
Hypophosphatemia
4%
Pulmonary edema
4%
Hypomagnesemia
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%
Blood culture positive
4%
Agitation
4%
Brain herniation
4%
Potassium decreased
3%
Ischemia
3%
Urine output increased
3%
Tachypnea
3%
AST increased
3%
Hypoxic brain damage
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%
Escherichia urinary tract infection
2%
Ventricular tachycardia
2%
Metabolic acidosis
2%
Base excess decreased
2%
Anasarca
2%
Fluid overload
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%
Diaphragmatic hernia
1%
Hemodynamic instability
1%
Anisocoria
1%
Distended abdomen
1%
Edema of extremities
1%
Urinary tract infection bacterial
1%
CRP increased
1%
Sinus tachycardia
1%
Hemoglobin decreased
1%
Adrenal insufficiency
1%
Hepatomegaly
1%
Urine candida
1%
Hematocrit low
1%
Loss of gag reflex
1%
Pseudomonas aeruginosa infection NOS
1%
Decreased hemoglobin
1%
Rib fracture
1%
Red man syndrome
1%
Collapse of lung
1%
Escherichia coli infection
1%
Respiratory syncytial virus infection
1%
Aspartate aminotransferase increased
1%
Streptococcus viridans group infection
1%
Hyperbilirubinemia
1%
Gram-positive cocci infection
1%
Polyuria
1%
Pneumatosis intestinalis
1%
Serous otitis media (glue ear)
1%
INR decreased
1%
Septic shock
1%
CPK increase
1%
Hyperthermia
1%
Edema of lower extremities
1%
Multi-organ disorder
1%
Staphylococcus aureus pneumonia
1%
APTT decreased
1%
PCO2 increased
1%
Decreased ventricular afterload
1%
WBC increased
1%
Cerebral ischemia
1%
Renal function aggravated
1%
Aspiration
1%
Emphysema
1%
Coughing
1%
Wheezing
1%
Shock vascular
1%
Candida albicans infection
1%
Tracheitis
1%
Multi-organ failure
1%
Sepsis
1%
Bloody airway discharge
1%
Asthma
1%
Stools watery
1%
Swallowing disorder
1%
Spinal epidural hematoma
1%
B-type natriuretic peptide
1%
Hypochloremia
1%
Unspecified disease of respiratory system
1%
Hypercarbia
1%
Poor peripheral perfusion
1%
Face oedema
1%
Liver failure
1%
Extravasation
1%
Arterial blood pH decreased
1%
Renal injury
1%
Tibia fracture
1%
BUN increased
1%
Clonus
1%
Sodium low
1%
Hypoproteinemia
1%
Pharyngeal edema
1%
Dilatation pupillary
1%
Ischemia cerebral
1%
DIC
1%
Acute renal failure
1%
Myocardial depression
1%
Premature ventricular contractions
1%
GI bleed
1%
Generalized edema
1%
Bacteria blood identified
1%
Transaminitis
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%
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%
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
ICECAP 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
2,701 Previous Clinical Trials
7,505,076 Total Patients Enrolled
1 Trials studying Cardiac Arrest
89 Patients Enrolled for Cardiac Arrest
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
647,559 Total Patients Enrolled
1 Trials studying Cardiac Arrest
34 Patients Enrolled for Cardiac Arrest
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,376,258 Total Patients Enrolled
3 Trials studying Cardiac Arrest
639 Patients Enrolled for Cardiac Arrest
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure and heart rate are stable.You have plans to stop life support soon.I am 18 years old or older.I joined the study within 6 hours of starting cooling treatment.You have received specific treatment to control your body temperature.You have a serious illness that is not expected to get better.I was in a coma after being resuscitated from a cardiac arrest outside of a hospital.My cardiac arrest was likely caused by sepsis.I have a neurological condition that could affect study results.You have had a cardiac arrest and your body temperature dropped below 34 degrees Celsius for 240 minutes or more.
Research Study Groups:
This trial has the following groups:- Group 1: 24 hour - non-shockable
- Group 2: 48 hours - non-shockable
- Group 3: 18 hours - shockable
- Group 4: 30 hours - shockable
- Group 5: 42 Hours - shockable
- Group 6: 6 hours - shockable
- Group 7: 24 hours - shockable
- Group 8: 60 hours - shockable
- Group 9: 60 hours - non-shockable
- Group 10: 6 hours - non shockable
- Group 11: 72 hours - non-shockable
- Group 12: 72 hours - shockable
- Group 13: 12 hours - shockable
- Group 14: 42 hours - non-shockable
- Group 15: 12 hours - non-shockable
- Group 16: 36 hours - non-shockable
- Group 17: 18 hours - non-shockable
- Group 18: 36 hours - shockable
- Group 19: 48 hours - shockable
- Group 20: 30 hours - non-shockable
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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