Clinical trial NCT02544542: Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage
Official title: A Comparative Clinical Trial of a New Rectum Cooling System Versus Temperature-adjusting Blanket on Patients of Hypoxic-ischemic Brain Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Keywords: Mild Hypothermia
Hypoxic-Ischemic Encephalopathy
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Chongqing Science and Technology Commission
First posted: 2015-09-09
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.

Detailed description: Mild hypothermia therapy has been proved to be beneficial to patients with severe traumatic brain injury. Currently a variety of cooling methods can achieve mild hypothermia,the hyper-hypothermia blanket being the most widely-used one.

Hyper-hypothermia blanket is a waterbed mattress connected to a thermostat-controlled water tank. Water is cooled in the tank and recycled between the tank and the mattress so that the patients sleeping on the mattress can be stably cooled. The operation is basically program-controlled ,but the whole system is quite expensive.

The investigators came up with a new cooling system which is very simple and accessible. A condom inserted with two 10# gastric tube and one 6# gastric tube and ringed with a rubber band is inserted into the patient's rectum, and ice-cold saline is pumped in through one 10# gastric tube and drained out from the other 10# gastric tube, the 6# gastric tube connected to the pressure monitor. Cooling rate is controlled by the flow speed of cold saline. The investigators will evaluate the effectiveness and safety of this new method for achieving mild hypothermia.

Eligibility criteria: Inclusion Criteria:

* Neonatal HIE
* After cardiopulmonary resuscitation (CPR)
* Severe craniocerebral injury (GCS \< 8)
* Acute central nervous system infection and severe brain edema or lasting convulsion
* Severe cerebral edema caused by various metabolic factors

Exclusion Criteria:

* End-stage heart failure
* Uncorrected serious cardiovascular dysfunction
* Active intracranial hemorrhage not under control
* Platelet count \< 50 \* 10\^9 / L

Primary outcomes:
measure: Rate of Cooling
timeFrame: 4 hours
measure: Body Temperature Fluctuations in Maintenance Phase
timeFrame: 12 hours
measure: Rate of Rewarming
timeFrame: 24 to 48 hours
Secondary outcomes:
measure: Incidence of Complications
timeFrame: 24 to 72 hours
measure: Fecal Occult Blood Testing Results Before and After the Therapy
timeFrame: Within 24 hours before the therapy and 48 to 72 hours after the therapy
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Zelan Zuo, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polderman KH, Herold I. Therapeutic hypothermia and controlled normothermia in the intensive care unit: practical considerations, side effects, and cooling methods. Crit Care Med. 2009 Mar;37(3):1101-20. doi: 10.1097/CCM.0b013e3181962ad5.
citation: Polderman KH. Mechanisms of action, physiological effects, and complications of hypothermia. Crit Care Med. 2009 Jul;37(7 Suppl):S186-202. doi: 10.1097/CCM.0b013e3181aa5241.
citation: Badjatia N, Strongilis E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Mayer SA. Metabolic benefits of surface counter warming during therapeutic temperature modulation. Crit Care Med. 2009 Jun;37(6):1893-7. doi: 10.1097/CCM.0b013e31819fffd3.
citation: Thoresen M, Satas S, Loberg EM, Whitelaw A, Acolet D, Lindgren C, Penrice J, Robertson N, Haug E, Steen PA. Twenty-four hours of mild hypothermia in unsedated newborn pigs starting after a severe global hypoxic-ischemic insult is not neuroprotective. Pediatr Res. 2001 Sep;50(3):405-11. doi: 10.1203/00006450-200109000-00017.
citation: Steiner T, Friede T, Aschoff A, Schellinger PD, Schwab S, Hacke W. Effect and feasibility of controlled rewarming after moderate hypothermia in stroke patients with malignant infarction of the middle cerebral artery. Stroke. 2001 Dec 1;32(12):2833-5. doi: 10.1161/hs1201.99511.