Hypothermia Following Acute Spinal Cord Injury
Status: | Completed |
---|---|
Conditions: | Hospital, Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry, Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/11/2019 |
Start Date: | January 2007 |
End Date: | December 2018 |
Efficacy of Intravenously Instituted Hypothermia Treatment in Improving Functional Outcomes in Patients Following Acute Spinal Cord Injury
The purpose of this study is to investigate the long term outcome of patients who receive
hypothermia treatment for spinal cord injury. At this institution, intravascular hypothermia
has been used for certain patients with spinal cord injury for the past two years. This study
will collect data from vital signs and examinations while the patient is in the hospital and
also when they follow up as an outpatient after they are discharged or go to a rehabilitation
center. This data will then be analyzed and compared only to historically published data from
previous studies. The aim of this investigation is to determine if intravascular hypothermia
results in a beneficial outcome for patients with spinal cord injury.
hypothermia treatment for spinal cord injury. At this institution, intravascular hypothermia
has been used for certain patients with spinal cord injury for the past two years. This study
will collect data from vital signs and examinations while the patient is in the hospital and
also when they follow up as an outpatient after they are discharged or go to a rehabilitation
center. This data will then be analyzed and compared only to historically published data from
previous studies. The aim of this investigation is to determine if intravascular hypothermia
results in a beneficial outcome for patients with spinal cord injury.
It is standard practice at this institution for patients with complete acute spinal cord
injury to receive hypothermia. Incomplete injuries may also be treated with hypothermia. This
will be a prospective analysis of the data collected at our institution from patients with
acute spinal cord injury receiving the hypothermia protocol. The care of these patients will
not be affected by this research. Data for normothermia (37 degrees Celsius) will be obtained
from historical studies analyzing similar patient groups. Patients arriving to this emergency
department have a baseline neurological examination in a timely fashion prior to the
induction of hypothermia by a neurosurgical attending or resident. All patients have Magnetic
Resonance Imaging (MRI) of the injured spinal cord on admission. Patients that are intubated
and medically sedated prior to the initial exam by the neurosurgical team are excluded
because the exam at that time may be inaccurate. Patients receiving hypothermia are
transferred to the Neurosurgical ICU, intubated and sedated using muscle relaxants.
Additional forms of sedation including benzodiazepines or dexmedetomidine are routinely used
as an adjunct to curtail a shivering response. For all patients receiving hypothermia, an
Alsius CoolGard® Icy Catheter is placed into the Inferior Vena Cava (IVC) via the femoral
vein and the temperature cooled to target (33 degrees) at the maximum rate (0.5 degrees/hr).
Mean arterial pressure (MAP) is kept >90 mm Hg at all times with fluid boluses (Normal Saline
or Albumin 5%) or blood transfusions to keep the hematocrit at 30. Hypothermia at 33 degrees
is maintained for 48 hours. Blood cultures are performed daily (from both a peripheral site
and from the catheter itself) and an Orogastric tube (OGT) or Nasogastric tube (NGT) is
placed in each patient. Nutrition is provided as per our current nutritional supplementation
protocol. Intravenous fluids consist of Normal Saline at all times unless the serum Na rises
above 160. Serum electrolytes, coagulation studies and complete blood count are performed
daily. After 48 hours of hypothermia, the patient is rewarmed to 37 degrees at a controlled
rate of 0.1 degree/hr. After reaching 37 degrees, the intravenous catheter is maintained for
no more than 6 days total to keep the systemic temperature at 37 degrees. Surface cooling
techniques are occasionally utilized for the purpose of maintaining normothermia after 6
days. The patients are discharged to rehabilitation after they are stabilized. All patients
will be reevaluated at 6 weeks, 6, and 12 months using the American Spinal Injury Association
(ASIA) sensory and motor scales with Functional Independence Measures (FIM). A follow-up MRI
scan will be done at one year.
injury to receive hypothermia. Incomplete injuries may also be treated with hypothermia. This
will be a prospective analysis of the data collected at our institution from patients with
acute spinal cord injury receiving the hypothermia protocol. The care of these patients will
not be affected by this research. Data for normothermia (37 degrees Celsius) will be obtained
from historical studies analyzing similar patient groups. Patients arriving to this emergency
department have a baseline neurological examination in a timely fashion prior to the
induction of hypothermia by a neurosurgical attending or resident. All patients have Magnetic
Resonance Imaging (MRI) of the injured spinal cord on admission. Patients that are intubated
and medically sedated prior to the initial exam by the neurosurgical team are excluded
because the exam at that time may be inaccurate. Patients receiving hypothermia are
transferred to the Neurosurgical ICU, intubated and sedated using muscle relaxants.
Additional forms of sedation including benzodiazepines or dexmedetomidine are routinely used
as an adjunct to curtail a shivering response. For all patients receiving hypothermia, an
Alsius CoolGard® Icy Catheter is placed into the Inferior Vena Cava (IVC) via the femoral
vein and the temperature cooled to target (33 degrees) at the maximum rate (0.5 degrees/hr).
Mean arterial pressure (MAP) is kept >90 mm Hg at all times with fluid boluses (Normal Saline
or Albumin 5%) or blood transfusions to keep the hematocrit at 30. Hypothermia at 33 degrees
is maintained for 48 hours. Blood cultures are performed daily (from both a peripheral site
and from the catheter itself) and an Orogastric tube (OGT) or Nasogastric tube (NGT) is
placed in each patient. Nutrition is provided as per our current nutritional supplementation
protocol. Intravenous fluids consist of Normal Saline at all times unless the serum Na rises
above 160. Serum electrolytes, coagulation studies and complete blood count are performed
daily. After 48 hours of hypothermia, the patient is rewarmed to 37 degrees at a controlled
rate of 0.1 degree/hr. After reaching 37 degrees, the intravenous catheter is maintained for
no more than 6 days total to keep the systemic temperature at 37 degrees. Surface cooling
techniques are occasionally utilized for the purpose of maintaining normothermia after 6
days. The patients are discharged to rehabilitation after they are stabilized. All patients
will be reevaluated at 6 weeks, 6, and 12 months using the American Spinal Injury Association
(ASIA) sensory and motor scales with Functional Independence Measures (FIM). A follow-up MRI
scan will be done at one year.
Inclusion Criteria:
- 18 - 65 years of age, ASIA (American Spinal Injury Association) Impairment Scale (AIS)
Score A or B, non-penetrating injury, and absence of severe systemic injury or
coagulopathy. Patients urgently taken to the OR for reduction may also be included.
Exclusion Criteria:
- Age > 65 years, ASIA (American Spinal Injury Association) Impairment Scale (AIS) Score
C or D, Hyperthermia on admission (> 37 degrees Celsius), Severe systemic injury,
Severe bleeding, Pregnancy, Coagulopathy, Thrombocytopenia, Known prior cardiac
history, Blood dyscrasia, Pancreatitis, Raynuad's syndrome, Penetrating spinal column
injury (gunshot and knife wounds etc.), Cord transection. Patients who are intubated
and sedated prior to initial examination by the neurosurgical team and patients
showing an improvement in the neurologic exam within 12 hours from the injury will
also be excluded.
We found this trial at
1
site
1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Miami, Florida 33136
Principal Investigator: Allan D Levi, MD, PhD
Phone: 305-243-2088
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